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Review of Developments in GMP and the Regulation of Medicines November 2021


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Vol 26-4B Nov 2021
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INTRODUCTION


During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from the UK, EU, USA, PIC/S and Australian regulatory authorities.


The topics covered in this edition of the “Update” include:



MHRA

  • Great Britain Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs)

  • Consultation on the future regulation of medical devices in the United Kingdom

  • Clear guidance to support bringing e-cigarettes to market as licensed therapies



European Medicines Agency (EMA)

  • Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia

  • Compilation of Union Procedures on inspections and exchange of information

  • Mid-year report

  • Highlights of Management Board – October 2021

  • Generating high-quality evidence from registry-based studies

  • Tailored Scientific Advice for biosimilar development. Report on the experience from the pilot (2017-2020)

  • EMA encourages companies to submit type I variations for 2021 in November 2021

The European Directorate for the Quality of Medicines & HealthCare (EDQM)

  • PDG prepares pilot for global expansion of membership

  • CEP holders invited to comment on draft monographs published in Pharmeuropa 33.4

  • Implementation of the European Pharmacopoeia Supplement 10.7.

  • Revised osmolality chapter for public comment

  • New & replacement reference standards


  • ICH Q13 continuous manufacturing of drug substances and drug products

  • S1B(R1) addendum to S1B testing for carcinogenicity of pharmaceuticals

  • Q&A Medical Product Communications That Are Consistent With the FDA-Required Labeling

  • Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling

  • Hospital and Health System Compounding Under Section 503A of the FD&C Act

  • Data standards for drug and biological product submissions containing real-world data

  • Reporting amount of listed drugs and biological products technical conformance guide



Australia TGA

  • Advice on recognition of COVID-19 vaccines not registered in Australia but used internationally

  • Performance statistics report 2020-21

International Coalition of Medicines Regulatory Authorities (ICMRA)

  • Statement on Pre-Requisites for Regulatory Flexibility in Pharmaceutical Manufacturing Change Management


  • EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19

  • EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)

  • EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11

  • EMA starts rolling review of molnupiravir

  • Spikevax: EMA recommendation on booster

  • First-in-class medicine to treat aggressive form of breast cancer

  • Additional manufacturing site for COVID-19 Vaccine Janssen

  • ICH M7 guideline to calculation of compound-specific acceptable intakes Addendum to M7(R2)


  • EMA Public stakeholder meeting on COVID-19 vaccines and therapeutics in the EU

  • Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS)


RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS


UK


MHRA

Great Britain Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs)

All existing CAP MAs have been automatically converted into Great Britain MAs effective from 1 January 2021 in Great Britain only (England, Wales and Scotland) and have been issued with a Great Britain Product Licence (PLGB) MA number. These Great Britain MAs are referred to as “converted EU MAs”. As a result of the implementation of the Northern Ireland Protocol, existing CAPs will remain valid for marketing products in Northern Ireland. MAHs had the option to opt-out of the conversion process for all or some of their CAPs by notifying the MHRA in writing.

Consultation on the future regulation of medical devices in the United Kingdom

The industry version of the recent webinar is now available and can be viewed online

Clear guidance to support bringing e-cigarettes to market as licensed therapies

The MHRA is committed to responding to the Tobacco Control Plan and supports the UK Government’s vision for a smoke-free generation by encouraging safe, high-quality and effective e-cigarette products to be licensed as medicines. This updated guidance comes after a consultation with the E-Cigarette Expert Working Group, a group of UK experts who provided independent oversight and advice to the MHRA.

The updated guidance provides further details on the steps required to license an e-cigarette as a medicinal product.

As stated in the Department of Health and Social Care 2017 Tobacco Control Plan, the evidence is clear that e-cigarettes are less harmful to health than smoking tobacco. The MHRA will continue to support companies in the development of safe and effective e-cigarette products, to encourage the licensing of e-cigarette products as medicines in order to support patient-centred care and access.

The MHRA seeks to encourage the licensing of electronic cigarettes (e-cigarettes) and other inhaled NCPs as medicines and aims to support companies to submit marketing authorisation applications for these products. In addition to the medicines authorisation, where the E-cigarette is refillable and re-useable, it will need to meet the UK Medical Device Regulations 2002 (as amended). Potential applicants who are not familiar with medicines legislation are strongly advised to contact the MHRA for regulatory and scientific advice. E-cigarettes regulated as medicines may be made available in strengths and volumes greater than those permitted under the TRPR (i.e. containing more than 20 mg/ml nicotine, more than 2 ml for single use cartridge/disposable products or more than 10 ml for refill containers).

[There were moves in this direction several years ago whilst UK was still part of the EU with MHRA appearing to be a strong advocate of such an approach. The EU / EMA did not however support such a move]



Europe


EMA

Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia

While marketing authorisation holders may develop medicines for uses in other indications, sometimes they lack the incentives or the commercial interest to pursue the necessary research and development and complete the regulatory process needed for the authorisation of a new indication for old medicines which are no longer protected by a patent or data exclusivity. This could be a wasted opportunity for public health.

EMA and the Heads of Medicines Agencies (HMA) are launching a pilot project to support the repurposing of medicines. The aim of this initiative is to support not-for-profit organisations and academia to gather or generate sufficient evidence on the use of an established medicine in a new indication with the view to have this new use formally authorised by a regulatory authority. This is a way of making new treatment options available to patients. As part of the pilot, EMA and the national medicines agencies will provide regulatory support, primarily scientific advice, to help these stakeholders generate a data package robust enough to support a future application by a pharmaceutical company.

The pilot will run until the completion of scientific advice for the selected repurposing candidate projects and optimally until the filing of an application by a pharmaceutical company for the new indication.

A report will be published after the pilot.

As a result of this initiative EMA has issued an update to its scientific advice and protocol assistance web page where a section on scientific advice on medicine repurposing has been added.

Compilation of Union Procedures on inspections and exchange of information

The Compilation of Union Procedures on Inspections and Exchange of Information (hereafter referred to as ‘Compilation’), formerly known as the Compilation of Community Procedures on Administrative Collaboration and Harmonisation of Inspections, is a tool for facilitating co-operation between the GMP and GDP inspectorates of the Member States and a means of achieving harmonisation. The procedures within it provide the basis for national procedures that form part of the national GMP inspectorates’ quality systems. These quality systems are based on a framework laid down in one of the documents of the Compilation.

EMA has issued revision 18 of this document.

Sections identified as new include:-

  • Management and classification of reports of suspected quality defects in medicinal products and risk-based decision-making

  • Procedure for managing rapid alerts arising from quality defects risk assessment

  • Outline of a Procedure for Co-ordinating the Verification of the GMP Status of Manufacturers in Third Countries

  • The Issue and Update of GMP Certificates

  • Procedure for dealing with serious GMP non-compliance requiring co-ordinated measures to protect public or animal health

  • Procedure for dealing with serious GMP non-compliance information originating from third country authorities or international organisations

  • Procedure for compliance management

  • Interpretation of the Union format for Manufacturer/Importer Authorisation

  • Interpretation of the Union format for a wholesale distribution authorisation (medicinal products for human use)

  • Union format for a GMP certificate

  • Statement of non-compliance with GMP

[This is a 295 page document but essential reading for any QA unit involved in dealing with supply of medicines into the EU. For existing and prospective QPs I would call it a MUST READ MBH]

Mid-year report 2021

This report was prepared by the Executive Director of the European Medicines Agency (EMA) and presented to the Agency's Management Board on 7 October 2021.

Highlights of Management Board – October 2021

The Management Board heard an update on recent activities in response to the pandemic. Since the last update in June. The Board was updated on the status of the Agency’s ongoing COVID-19 lessons learned exercise. As part of this exercise, some of the measures and actions taken by EMA and the network in response to the pandemic are being discussed and reflected upon across a number of areas including support for rapid research and development, rapid authorisation procedures, safety and effectiveness monitoring post-authorisation, workload and resourcing, and transparency and communication on COVID-19-related issues.

Generating high-quality evidence from registry-based studies

Medicine regulators may sometimes suggest that pharmaceutical companies use the data collection infrastructure or population of a patient registry to exploit information from clinical use and to monitor the safety and effectiveness of authorised medicines when used in the real-world setting.

There can be significant differences in requirements for types, structures and processing of data across existing registries. These often present challenges in the assessment of the suitability of existing registries to be used in clinical studies.

This guideline aims to help those involved in registry-based studies to better define study populations and design study protocols; it provides further guidance on data collection, data quality management and data analysis to achieve higher quality evidence. This in turn will facilitate EU regulators’ assessment of the safety and effectiveness of medicines, for the benefit of public health.

As patient registries are key to conducting registry-based studies, the guidance includes an annex with good practices in the establishment and management of patient registries and their use for other regulatory purposes.

[See also the ’Real World Evidence /data’ item in the USA section of this month’s report. In themselves these items perhaps indicate a new approach by both regulators and industry towards the ongoing validation of effectiveness of medicines MBH]

Tailored Scientific Advice for biosimilar development. Report on the experience from the pilot (2017-2020)

In April 2020, the pilot was completed. Data on the pilot and an analysis of the experience is presented in the report. Applicants participating in the pilot appreciated the possibility to present and discuss with regulators their quality comparability data and considered the comprehensiveness of this type of advice very important to gain clarity and confidence in their programme. They consider this type of scientific advice as a valuable opportunity to decide on open questions and a tool to have more in-depth dialogue with regulators and resulting guidance. The expectation from regulators to perform a detailed review of quality data to inform on the extent of the non-clinical and clinical data needed to be generated was in most cases limited by the lack of mature quality packages. The advice given had, in most instances, more impact on the generation of quality data per se and less impact on clinical data requirements than anticipated. It would therefore need to be seen how biosimilar development programmes can be adapted to allow potentially reduced animal and clinical study requirements to be considered. Considering that the scientific discussions held for this type of advice have been regarded as beneficial and acknowledging the need to further mature the experience based on specific cases, the tailored scientific advice offering for biosimilar development will be continued as part of regular scientific advice operations. To account for the more in-depth review and to allow sufficient time for the scientific assessment and discussion the duration of the procedure is set to 70 days if managed without discussion meeting (100 days if a discussion meeting is needed). The number of requests is capped to a maximum of two procedures per month in order to manage the foreseen resource requirements.

EMA encourages companies to submit type I variations for 2021 in November 2021

EMA is advising marketing authorisation holders (MAH) to submit type IA and type IAıɴ variations for 2021 no later than 30 November 2021. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 23 December 2021 and 3 January 2022.

MAHs are advised to submit any type 1B variations or groupings of type IBs and type IAs by 3 December 2021 for a start of procedure in 2021. For submissions received on or after 6 December 2021, the procedure may not start until January 2022.

For veterinary medicines, MAHs are advised to submit any type 1B variations or groupings of type IBs and type IAs by 15 November 2021 for a start of procedure in 2021.


EDQM

PDG prepares pilot for global expansion of membership

The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), with the World Health Organization (WHO) as an observer, is preparing a pilot to integrate additional world pharmacopoeias. This is a critical step in the PDG’s commitment to expanding recognition of harmonised pharmacopoeial standards with a view to achieving global convergence.

CEP holders invited to comment on draft monographs published in Pharmeuropa 33.4

Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.4.

Implementation of the European Pharmacopoeia Supplement 10.7.

Supplement 10.7 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 April 2022

Revised osmolality chapter for public comment

Ph. Eur. is seeking stakeholder feedback on the revised general chapter on Osmolality (2.2.35), (deadline for comment 31 December 2021). It should be noted that the group of experts in charge used the revision opportunity to overhaul the information given in this general chapter and bring it in line with the latest requirements.

New & replacement reference standards

EDQM announces availability of 4 new Ph. Eur. reference standards and 21 replacement batches for Ph. Eur. reference standards.



United States of America


The US Food and Drug Administration (USFDA)

FDA has recently published 2 ICH documents for comment. These are:-

ICH Q13 continuous manufacturing of drug substances and drug products

This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidelines, this guideline provides clarification on CM concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products. This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. It is applicable to CM for new products (e.g., new drugs, generic drugs, biosimilars) and the conversion of batch manufacturing to CM for existing products. The principles described in this guideline may also apply to other biological/biotechnological entities.

S1B(R1) addendum to S1B testing for carcinogenicity of pharmaceuticals

This Addendum covers all small molecule pharmaceuticals where carcinogenicity evaluations are recommended as described in S1A. This Addendum expands the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals by introducing an additional approach that is not described in the original S1B Guideline. This is an integrative approach that provides specific weight of evidence [WoE] criteria that inform whether or not a 2-year rat study adds value in completing a human carcinogenicity risk assessment. The Addendum also adds a plasma exposure ratio-based approach for setting the high dose in the rasH2-Tg mouse model,1 while all other aspects of the recommendations for high dose selection in S1C(R2) Guideline would still apply. Application of this integrative approach would reduce the use of animals in accordance with the 3Rs (reduce/refine/replace) principles, and shift resources to focus onto generating more scientific mechanism-based carcinogenicity assessments, while promoting safe and ethical development of new small molecule pharmaceuticals.

Q&A medical product communications that are consistent with the FDA-required labeling

This guidance provides information for firms about how FDA evaluates firms’ medical product communications that fall within the scope of FDA’s regulatory authority (product communications) and that present information not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product.

Medical product firms have told FDA that they are interested in communicating, including in their promotional materials, data and information about the approved/cleared uses of their products that are not contained in their products’ FDA-required labeling. FDA also recognizes that firms have questions about how FDA determines whether product communications that contain data and information that are not in the FDA-required labeling are consistent with that labeling. The purpose of this guidance is to provide clarity regarding FDA’s thinking when examining the consistency of a firm’s product communications with that product’s own FDA-required labeling. As explained in section III (Q.3/A.3), if a firm communicates information that is not contained in its product’s FDA-required labeling but that is determined to be consistent with the FDA-required labeling, FDA does not intend to rely on that communication to establish a new intended use.

Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling

This final guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for prescription drugs. The disclosure of the product name in promotional labeling and advertisements is important for proper identification and to ensure safe and effective use. This guidance also articulates the circumstances under which FDA intends to refrain from taking enforcement action regarding these requirements.

FDA believes that following this guidance will allow for appropriate advertising and promotion without presenting any public health risk to patients.

Hospital and Health System Compounding Under Section 503A of the FD&C Act

Pharmacies located within a hospital, or standalone pharmacies that are part of a health system, frequently provide compounded drug products for administration within the hospital or health system. Some of these compounders seek to compound drugs under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This revised draft guidance describes how FDA intends to apply certain provisions of section 503A of the FD&C Act to human drug products that are compounded by state-licensed pharmacies that are not outsourcing facilities for distribution within a hospital or health system.

First, the revised draft guidance addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient. Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product

Data standards for drug and biological product submissions containing real-world data

The 21st Century Cures Act, is intended to accelerate medical product development and bring innovations faster and more efficiently to the patients who need them. Among other provisions, the 21st Century Cures Act added section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355g). Pursuant to this action, calling for FDA to issue guidance on the use of real-world evidence (RWE) in regulatory decision-making, FDA has created a framework for a program to evaluate the potential use of real-world data (RWD) to generate RWE to help support the approval of new indication(s) for drugs already approved under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) or to help support or satisfy post-approval study requirements (RWE Program). This guidance provides recommendations to sponsors for complying with section 745A(a) of the FD&C Act (21 U.S.C. 379k-1(a)) when submitting RWD as study data in applicable drug submissions. FDA is issuing this guidance as part of its RWE Program and to satisfy, in part, the mandate under section 505F of the FD&C Act (21 U.S.C. 355g) to issue guidance on the use of RWE in regulatory decision-making. This guidance addresses considerations for the use of data standards currently supported by FDA in applicable drug submissions containing study data derived from RWD sources. For the purposes of this guidance, FDA defines RWD as data relating to individual patient health status or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data from electronic health records (EHRs); medical claims data, data from product and disease registries; patient-generated data (including data from in-home-use settings); and data gathered from other sources that can inform on health status, such as mobile devices.

Reporting amount of listed drugs and biological products technical conformance guide

The CARES Act was enacted to aid response efforts and ease the economic impact of the Coronavirus Disease 2019 (COVID-19). The CARES Act includes authorities to enhance FDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, improving FDA’s visibility into drug supply chains. Section 3112(e) of the CARES Act

added new section 510(j)(3) to the FD&C Act. Under section 510(j)(3), each person (including repackers and relabelers) who registers under section 510 of the FD&C Act with regard to a drug must report to FDA annually the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.

FDA is issuing this Technical Conformance Guide (guide) to assist registrants of drug establishments (or their authorized agents) in submitting reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution



International


Australia TGA


Therapeutic Goods Administration (TGA)

TGA advice on recognition of COVID-19 vaccines not registered in Australia but used internationally

TGA has undertaken an assessment on the protection offered by certain COVID-19 vaccines that are administered in certain countries but not currently registered in Australia. In this initial report the TGA assessed six vaccines that have been widely deployed in the Asia-Pacific region, as well as in national vaccination programs in countries such as China and India from which Australia normally receives many international arrivals. Following assessment to determine the protection offered by certain of these vaccines against infection and serious illness, TGA's initial advice is that Coronavac (Sinovac) and Covishield (AstraZeneca/Serum Institute of India) vaccines be considered 'recognised vaccines' for incoming international travellers to be regarded as appropriately vaccinated.

TGA has received insufficient data to reach a conclusion as to the protection offered by BIBP-CorV (Sinopharm), Covaxin (Bharat Biotech), Sputnik V (Gamaleya Institute), and Convidecia (CanSino). These vaccines could be recognised in the coming weeks or months as more data becomes available.

All four COVID-19 vaccines which have been granted provisional approval in Australia - from Pfizer (Comirnaty), AstraZeneca (Vaxzevria), Moderna (Spikevax) and COVID-19 Vaccine Janssen are also recognised for incoming travellers.

The TGA has undertaken this work at the request of government.

Performance statistics report 2020-21

Each year TGA provides information about its regulatory performance through the TGA Annual Performance Statistics Report and the Half Yearly Performance Snapshot. We also report annually on our performance against the Regulator Performance Framework through the TGA Self-Assessment (Key Performance Indicators) Report. The statistics contained within this report cover the period 1 July 2020 to 30 June 2021 and contribute to annual publications that track our progress against the priorities we have established for the financial year


ICMRA

Statement on Pre-Requisites for Regulatory Flexibility in Pharmaceutical Manufacturing Change Management

Since early 2020, medicines regulators and the pharmaceutical industry have worked together as part of ICMRA to advance innovation in development of new therapeutics and vaccines to address urgent unprecedented global needs caused by the COVID-19 pandemic. The scientific achievements of the past year have been remarkable, and effective vaccines and therapeutics have been authorised in many parts of the world. All efforts are now focusing on ensuring that these medicines are produced and made available on an unprecedented global scale. Therefore, it is important for ICMRA and industry stakeholders to interact with each other to further understand and exchange lessons learned from both sides and continue ensuring uninterrupted supply of medicines to patients.

On 7-8 July 2021, ICMRA and Industry stakeholders conducted a joint workshop with a focus on quality, as part of a joint international effort to accelerate the availability of the life-saving therapeutics and vaccines. The goal was to enhance regulators’ understanding of specific challenges faced by manufacturers who are seeking to increase manufacturing capacity for COVID-19 therapeutics and vaccines. Another aim was to improve industry’s awareness of current regulatory approaches that have been used to enable the rapid increase of manufacturing capacity for production of COVID-19 therapeutics and vaccines in different regions.

The experience shared in the workshop highlighted the most important enablers for industry to maximise the use of regulatory flexibilities introduced in response to the COVID-19 pandemic for supporting manufacturing and post-approval changes.



Products


EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19

EMA has started evaluating an application for marketing authorisation for the monoclonal antibody Regkirona (regdanvimab, also known as CT-P59) to treat adults with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID 19. The applicant is Celltrion Healthcare Hungary Kft.

EMA will assess the benefits and risks of Regkirona under a reduced timeline and could issue an opinion within two months, depending on the robustness of the data submitted and whether further information is required to support the evaluation.

EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)

EMA’s human medicines committee (CHMP) has started a rolling review of Evusheld (also known as AZD7442), , which is being developed by AstraZeneca AB for the prevention of COVID-19 in adults. This medicine is made of tixagevimab and cilgavimab, two monoclonal antibodies. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen). Tixagevimab and cilgavimab have been designed to attach to the spike protein of SARS-CoV-2 (the virus that causes COVID-19) at two different sites. By attaching to the spike protein, the medicine is expected to stop the virus from entering the body’s cells and causing infection. Because the antibodies attach to different parts of the protein, using them in combination may be more effective than using either alone.

EMA will communicate further when a marketing authorisation application for the medicine has been submitted.

EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11

EMA will communicate on the outcome of its evaluation, which is expected in a couple of months unless supplementary information is needed.

EMA starts rolling review of molnupiravir

EMA’s CHMP has started a rolling review of the oral antiviral medicine molnupiravir (also known as MK 4482 or Lagevrio), developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics for the treatment of COVID-19 in adults.

Spikevax: EMA recommendation on booster

EMA’s CHMP has concluded that a booster dose of the COVID-19 vaccine Spikevax (from Moderna) may be considered in people aged 18 years and above.

This follows data showing that a third dose of Spikevax given 6 to 8 months after the second dose led to a rise in antibody levels in adults whose antibody levels were waning. The booster dose consists of half the dose used for the primary vaccination schedule.

First-in-class medicine to treat aggressive form of breast cancer

EMA has recommended granting a marketing authorisation in the European Union (EU) for Trodelvy (sacituzumab govitecan), a first-in-class medicine to treat adult patients with unresectable (cannot be removed by surgery) or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for advanced disease.

EMA’s CHMP committee reviewed the application for marketing authorisation under an accelerated timetable to enable faster patient access to this medicine. The opinion adopted by the CHMP is an intermediary step on Trodelvy’s path to patient access.

The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.

Additional manufacturing site for COVID-19 Vaccine Janssen

EMA’s CHMP has approved an additional manufacturing site for the production of COVID-19 Vaccine Janssen.

The site, located in West Point, Pennsylvania in the United States, and operated by Merck Sharp & Dohme Corp, will manufacture finished product.


Documents


ICH M7 guideline to calculation of compound-specific acceptable intakes Addendum to M7(R2)

This addendum has been endorsed by the Members of the ICH Assembly under Step 2 and released for public consultation, deadline for comments is 8 Dec 2021.


Conferences


EMA Public stakeholder meeting on COVID-19 vaccines and therapeutics in the EU

This fourth public meeting will provide an update on COVID-19 vaccines and therapeutics in the EU. It will also address misinformation and highlight the current vaccination coverage in the EU. The event will also allow the public and stakeholders to further inform EMA of their needs, expectations and any concerns. No registration is required to follow the live broadcast and questions or comments can be submitted during the meeting.

Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS)

The way clinical trials are conducted in the European Union will change when the Clinical Trials Regulation (Regulation (EU) No 536/2014) becomes applicable on 31 January 2022 and the Clinical Trials Information System (CTIS) will go live.

EMA is organising a webinar to inform small and medium-sized enterprises (SMEs) and academic sponsors of clinical trials on how to prepare for the main changes brought by the Regulation and its impact on their trial-related activities.

Topics presented during the webinar include:

  • an overview of the Clinical Trials Regulation

  • an introduction to the new process for submitting clinical trial information in the European Union/European Economic Area

  • functionalities of CTIS, including transparency aspects and safety reporting requirements

  • guidance and training material available for sponsors

Presentations are given by EMA experts and representatives of the European Commission, national competent authorities, SMEs and academia.

The event will be broadcast live. A video recording will be made available later.

[Active participation is by invitation only and limited to SMEs registered with EMA, academia and representatives of stakeholder organisations. Only registered participants will be able to participate actively. MBH]



And finally…

Further information on these and other topics can be found in recent versions of the “Regulatory Update” on the PHSS website (members area) by utilising the hyperlink within that particular Update.

We hope that our readers find our reviews to be both informative and helpful in keeping up to date with pharmaceutical legislation and regulatory guidance.


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