Review of Developments in GMP and the Regulation of Medicines May 2025 

EJPPS vol 30.2B 

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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, WHO regulatory authorities and ICH.

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

UK

Medicines and Healthcare products Regulatory Agency (MHRA)

·         Vital role in ensuring the quality of global biological medicines 

·         New opportunities to drive medical breakthroughs for patients

·         Clinical Trials regulations signed into law

·         CBD products marketed for medical purposes

·         MHRA Performance Data

·         MHRA’s biggest ever crackdown on organised medicines trafficking

EU

European Medicines Agency (EMA)

·         Guidance on GMP and GDP: Q&A

·         Reflection paper on a tailored clinical approach in biosimilar development

·         Active substance The QP Declaration Template Q&A

·         Consultation on a potential Key Information Section in the Package Leaflet of centrally authorised medicinal products

·         Tackling vulnerabilities in the supply chain of radiopharmaceuticals in the EU

·         Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to address vulnerabilities in the supply chain of radiopharmaceuticals

·         QRD annotated template v11

·         ICH Q1 stability studies for drug substances and drug products

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

·         Pharmeuropa 37.2

·         Revised general chapters for elemental analysis published in Pharmeuropa 37.2

·         Outcome of the 181st session of the European Pharmacopoeia Commission

·         Groundbreaking chapter on cell-based preparations for human use

·         Public consultation on revised general chapter 5.1.6. Alternative methods for control of microbiological quality.

·         Certification monthly report end of March 2025

·         HTS chapter to enhance viral contaminant detection in biological products 

United States of America

The US Food and Drug Administration (USFDA)

·         Post election status

International

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

·         Bioequivalence for immediate-Release solid oral dosage forms - Additional strengths biowaiver M13B.

World Health Organisation (WHO)

·         good practices for quality control of radiopharmaceutical products

·         58th Expert Committee on Specifications for Pharmaceutical Preparations

Products

·         Trastuzumab deruxtecan approved to treat adults with HER2-positive cancer that has spread or cannot be removed by surgery

·         MHRA approves first UK treatment for Friedreich’s ataxia, omaveloxolone

·         Marstacimab approved to treat patients aged 12 years and above with haemophilia A or B

·         Obecabtagene autoleucel conditionally approved to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia

·         Acoramidis approved to treat wild-type or variant transthyretin amyloidosis in adults with cardiomyopathy

·         MHRA authorises cancer treatment variation with an administration time of 3–5 minutes

Conferences, webinars etc.

·         Sterile substance CEP webinar on 4th June 2025

·         EMA’s 30th anniversary scientific conference - Medicines, regulation and the future

·         PHSS Sterile Product Conference 2025

·         PHSS Annual Conference 2025

·         PHSS - QP Forum Conference 2025

RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS

UK

Medicines and Healthcare products Regulatory Agency (MHRA)

Vital role in ensuring the quality of global biological medicines 

WHO has confirmed the successful redesignation of the MHRA’s Science and Research group as one of its Collaborating Centres for the Standardisation and Evaluation of Biologicals for the next four years.

This is critical for the work this group at the MHRA does on behalf of the WHO to develop, produce and distribute physical standards that are applied to assure the quality of biological medicines. 

The Science and Research group at the MHRA, and formerly the National Institute for Biological Standards and Control (NIBSC), was granted its first designation back in 1954, and is one of only four institutes worldwide that WHO designates as a custodian laboratory for its International Biological Reference Preparations. 

New opportunities to drive medical breakthroughs for patients

New analysis of the current clinical trial landscape in the UK shows clear opportunities to shape the future of medical research and patient care.

Published in the British Journal of Clinical Pharmacology, the report offers the most detailed picture yet of the UK’s clinical trials landscape. It finds strong innovation – but also a concentration of research in certain disease areas, and opportunities for increased representation of certain patient groups.

The MHRA is using the insights to build upon the country’s world-leading clinical research and deliver its new clinical trials regulations to create a more efficient, streamlined and adaptable regulatory framework. Working in partnership with patients, the NHS, industry and academia, the MHRA will support increased research into underrepresented conditions, improve diversity in trial participation, and attract further global investment in innovation.

Clinical Trials regulations signed into law

New regulations for running clinical trials in the UK have now been signed into law. A 12-month roll-out begins 11 April 2025 to deliver the most significant update to UK clinical trials regulation in two decades – with the aim of strengthening patient safety, accelerating approvals, enabling innovation and helping more people benefit from taking part in vital research.

The updated regulations are designed to put participants firmly at the centre of how trials are run, while supporting a faster, more streamlined approvals, making it easier to test new treatments in the UK.

The MHRA is committed to implementing a flexible and risk-proportionate regulation of clinical trials, which accelerates patient access to potentially life-saving medicines without compromising safety.

CBD products marketed for medical purposes

Products containing cannabidiol (CBD) used for medical purposes are medicines. If a company markets a CBD containing product that makes a medicinal claim it will be considered to fall within the definition of a medical product contained in The Human Medicines Regulations 2012.

Medicinal products must hold a Marketing Authorisation to allow their legal sale, supply, or advertisement in the UK (unless exempt). Authorised medicinal products must meet safety, quality, and efficacy standards as part of the authorisation process in place to protect public health.

It is for companies to consider whether they wish to market products that they regard to fall outside the definition of a medical product which are subject to regulation elsewhere (e.g. under food law). It is responsibility of those marketing a product to ensure that it is marketed in accordance with the relevant legislation.

MHRA can give no assurance that any particular product, including products under development, will not subsequently be classified as a medicinal product. Should companies wish to provide MHRA with evidence that demonstrates that the products fall outside the definition of a medicinal product, then MHRA is happy to consider this in the context of the ongoing work it is undertaking.

MHRA Performance Data

The MHRA 2024/25 business plan gave a commitment to our focus being the optimisation of our service delivery for customers. It introduced key performance indicators (KPIs) and a corporate objective to enhance the transparency and accessibility of our performance data. Here we provide the MHRA performance data for March 2025 for each KPI.

The aim is to help applicants with decision making, based on our performance data, and to ensure greater accountability for our service delivery.

MHRA’s biggest ever crackdown on organised medicines trafficking

Twelve suspects have been arrested in dawn raids in four counties across the West Midlands and the Northwest of England in the largest criminal investigation into organised medicines trafficking in the history of the MHRA.

The individuals have been arrested on suspicion of participating in the activities of an organised crime group, conspiracy to sell or supply controlled drugs and unlicensed medicines, and money laundering. Suspects are being held for questioning at police stations across the two regions.

In searches of 22 residential and commercial premises, hundreds of thousands of doses of medicines have been seized including controlled drugs such as opioid painkillers and anti-anxiety medicines, around £100,000 in cash, luxury watches and suspected criminal assets held in cryptocurrency. The MHRA has also obtained restraint orders for more than £3.5 million in assets suspected to be linked to criminal activity.

Europe

European Medicines Agency (EMA)

Guidance on GMP and GDP: Q&A

This Q&A was updated 08/04/2025: the impacted section is 'EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances' section.

New Q&As 3 & 9 are addressed:-

·         Q3-Is an audit performed by a 3^rd party acceptable?

·         Q9-What are the expectations for the content of written final assessment of 3^rd party audit reports?

Reflection paper on a tailored clinical approach in biosimilar development

This reflection paper will examine settings for biosimilars where similar clinical efficacy and safety can be inferred from a conclusion of physicochemical and biological similarity and comparable pharmacokinetics.

Currently, Comparative Efficacy Studies (CES) (in which safety and immunogenicity data are also routinely captured) can already be waived in case an accepted pharmacodynamic (PD) surrogate endpoint exists, but even this prerequisite might not be needed.

A tailored approach for clinical development of biosimilar candidates can be envisioned. In certain cases, CES may no longer be required for approval of biosimilars that can be thoroughly characterised and have shown high similarity on an analytical and in vitro pharmacology level. Comparative clinical pharmacokinetic studies are still essential elements in biosimilar development but some adjustments to the data requirements, such as inclusion of immunogenicity parameters and/or modifying the study design (e.g., one-dose vs multiple-dose), could be considered.

Active substance - The QP Declaration Template Q&A

The Qualified Person’s declaration concerning GMP compliance of the active substance manufacture “The QP declaration template” Has recently been updated as to third party audit(s) be reflected in part C of the QP declaration. In essence:-

·         If the audit is undertaken by the manufacturer and Importer Authorisation Holder (MIAH), the auditing body column should be left empty.

·         If the audit is performed by a third-party body (i.e. contract acceptor on behalf of the MIAH contract giver), this should be detailed as reflected in the contract.

·         In case the audit is performed on behalf of the MIAH by different entity/entities belonging to the same overall company, this should also be detailed in the auditing body column.

·         It is emphasised that in case the MIAH site does not perform the audit itself, the MIAH should be the contract giver. Consequently, the contract giver should always correspond to the MIAH site and the contract acceptor is expected to be the auditing body that actually performed the audit.

·         The same principles also apply in the case of sharing of audit reports between different MIAHs using the same active substance supplier.

Consultation on a potential Key Information Section in the Package Leaflet of centrally authorised medicinal products

EMA and the Quality Review of Documents (QRD) Working Group are currently working on the revision of the QRD template for centrally authorised medicinal products for human use, with the aim of improving the content and structure of the package leaflet and making it more understandable and relevant to patients, while still complying with the current legislative

framework.

The draft revised QRD template has been released for public consultation until 31 August 2025. Separate from the public consultation of the QRD template, the EMA would like to gather the views of stakeholders on the potential usefulness and added value of a new “key information section” in the package leaflet.

The evidence and views collected may help inform the decision on whether such a key information section in the package leaflet is needed and, if so, what type of information should be provided therein.

The EMA invited all interested stakeholders to respond to this survey by 31 May 2025.

Tackling vulnerabilities in the supply chain of radiopharmaceuticals in the EU

EMA and the Heads of Medicines Agencies (HMA) have issued recommendations to address vulnerabilities in the supply chain of radiopharmaceuticals. These types of medicines contain radioactive forms of chemical elements and are used to diagnose or treat medical conditions such as cancer. Their use is steadily increasing, while manufacturing capacity in Europe is limited. This has led to occasional shortages in different Member States.

Production of radiopharmaceuticals is reliant on stable isotopes and other materials that are sourced mainly from third countries. In addition, the supply chain of these medicines, including how to transport them safely, is complex.

The MSSG recommendations are directed to European and national authorities, as well as to industry with the aim to align efforts to address these issues.

Member States are advised to map their supply chains, coordinate transport solutions and consider the inclusion of new radiopharmaceuticals in horizon scanning activities. EMA will continue to support regulatory activities as necessary and ensure cooperation and coordination, while companies are encouraged to work with regulators and submit any necessary information.

Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to address vulnerabilities in the supply chain of radiopharmaceuticals

In 2024, the need to ensure security of supply for radioisotopes for medical use was highlighted in the Council conclusions on the security of supply of radioisotopes for medical use and the European Economic and Social Committee (EESC) “Europe’s Beating Cancer Plan: Driving forces for the security of medical radioisotopes supply”.

The MSSG, through the Medicine Shortages Single Point Of Contact Working Party (SPOC WP), has being monitoring availability issues of radiopharmaceuticals and providing regulatory support when possible, to prevent and/or mitigate the impact of shortages on patients. However, the regulatory tools available are limited to address the vulnerabilities in the supply chain of radiopharmaceuticals which would require long-term industrial policy measures.

Recommendations are offered to the European Commission, Member States, EMA, and Companies (MAHs and manufacturers).

QRD annotated template v11

The ongoing revision of the Quality Review Documents (QRD) template started in September 2023. This report is an assessment of shortcomings in the summary of product characteristics (SmPC) and the package leaflet (PL), and it provides some recommendations on how they could be improved to better meet the needs of patients and healthcare professionals.

The main changes in the QRD template intend to tackle the following aspects:-

• The recurrent issue of the length of the PL, hence the deletion of the introductory bullets and the optionality of the table of contents.

• The creation of new standard statements aimed at improving patient-friendliness as well as consistency across products.

• The relocation of some information that is deemed important enough to appear at the beginning of the leaflet.

• The grouping of information by subject, as patients tend to look for information related to

the same topic in the same place (e.g. interactions with food and drink merged with instructions on taking the medicine with food and drink).

• The reorganisation of warnings and precautions throughout the PL so that they follow the logics of what is important before, while, and after taking the medicine.

• The inclusion of a new optional section 7 for instructions for use when these are too extensive to be accommodated in section 3 or if they are related to a medical device accompanying the medicine.

ICH Q1 stability studies for drug substances and drug products

This stage 2b guideline outlines the stability data expectations for drug substances and drug products, it is applicable to marketed drug products, including those associated with registration and lifecycle/post-approval changes and, when applicable, master files. ICH Q1 is a consolidated revision that supersedes ICH Q1A-F and Q5C guidelines and provides additional guidance on principles relating to stability.

EMA has released the document for comment by 30 July 2025.

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

Pharmeuropa 37.2

All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 37.2 is 30 June 2025.

There are 54 new drafts.

Revised general chapters for elemental analysis published in Pharmeuropa 37.2

Analytical procedures for elemental analysis are described in the following European Pharmacopoeia (Ph. Eur.) general chapters:

·         2.2.22. Atomic emission spectrometry;

·         2.2.23. Atomic absorption spectrometry;

·         2.2.57. Inductively coupled plasma-atomic emission spectrometry;

·         2.2.58. Inductively coupled plasma-mass spectrometry.

The four general chapters have been revised and are presented in Pharmeuropa 37.2 for comment because similar recommendations and quality requirements ultimately apply to all of them and this was not previously reflected in their content and structure.

The revision process was also driven by the content of the ICH Q3D Guideline and the requirements of Ph. Eur. general chapter 2.4.20. Determination of elemental impurities, neither of which was in place when the four Ph. Eur. general chapters on elemental analysis were first published.

The main objective of the revision is to harmonise the following aspects

·         equipment performance;

·         sample preparation;

·         system suitability;

·         validation requirements.

Outcome of the 181st session of the European Pharmacopoeia Commission

A summary is available as an infographic. Highlights will be published shortly on the EDQM website and the full list of adopted texts will be made available later.

Groundbreaking chapter on cell-based preparations for human use

After several years of work by the Cell Therapy Products Working Party (CTP WP), the European Pharmacopoeia Commission (EPC) adopted the new general chapter Cell-based preparations for human use (5.32) during its 181st session in March 2025. The new chapter will be published in Issue 12.2 of the European Pharmacopoeia (Ph. Eur.) in October 2025 and will enter into force on 01 April 2026.

Public consultation on revised general chapter 5.1.6. Alternative methods for control of microbiological quality.

The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter 5.1.6. Alternative methods for control of microbiological quality, published in this quarter’s issue of Pharmeuropa 37.2 for comment. This chapter aims to facilitate the implementation of rapid microbiological methods (RMM), an expanding area of microbiology that is both innovative and diverse in nature. The revision of this chapter is part of the significant efforts made by the Ph. Eur. Commission (EPC) to support and accelerate the implementation of alternative RMMs, which are especially beneficial for short shelf-life products. By fulfilling stakeholder expectations in this fast-moving field.

General chapter 5.1.6 has undergone significant revision to reflect current methodologies and update implementation guidance for these alternative methods. It now clarifies the responsibilities of suppliers and users and includes new information to help users optimise implementation strategies by capitalising on suitable tests already performed and evaluating different implementation activities simultaneously.

Certification monthly report end of March 2025

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.

HTS chapter to enhance viral contaminant detection in biological products 

The European Pharmacopoeia Commission (EPC) adopted a new general chapter, High-throughput sequencing for the detection of viral extraneous agents (2.6.41), during its 181st session in March 2025. The new chapter will be published in Issue 12.2 of the European Pharmacopoeia (Ph. Eur.) in October 2025 and will enter into force on 01 April 2026.

High-throughput sequencing (HTS, also known as Next-Generation Sequencing) is a state-of-the-art and sensitive molecular biology technology increasingly used to test for viral extraneous agents in biological products. In contrast to conventional tests used for this purpose, HTS can detect a broad range of viruses, both known and unknown. HTS also offers advantages over conventional methods in terms of animal welfare as it may be used instead of in vivo tests.

United States of America

The US Food and Drug Administration (USFDA)

Post election status

There are currently no developments to report whilst the internal processes are ongoing.

International

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Bioequivalence for immediate-Release solid oral dosage forms - Additional strengths biowaiver M13B.

This guideline is intended to provide recommendations on obtaining waivers of bioequivalence (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths. The guideline is applicable during both development and post-approval phases of orally administered immediate release (IR) solid dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.

Deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided. Applicants are encouraged to consult the regulatory authority(ies) when an alternate approach is proposed or taken.

M13B is intended to reduce the need for in vivo BE studies for additional strengths by recommending the specific criteria needed to pursue a biowaiver of such studies.

The EMA has published this step 2B document for comment.

World Health Organisation (WHO)

Good practices for quality control of radiopharmaceutical products

The draft working document on the International Atomic Energy Agency (IAEA)/WHO guidelines on good practices for quality control of radiopharmaceutical products is now open for public consultation.

Implementation of a robust quality control system tailored to the unique nature of radiopharmaceuticals requires careful consideration. Radiopharmaceuticals possess inherent characteristics that demand specialized attention, including the narrow testing time window, variability in the types of emitted ionizing radiation, complexities associated with the simultaneous production of radioactive drug substances and final drug products, and the constraints of radiation handling. These factors must be systematically integrated into the design of radiopharmaceutical quality control processes. Concurrently, however, radiopharmaceutical quality control testing must be sufficiently comprehensive and well- integrated into the overall production process, as its function ensures that the radiation administered to the patient provides the intended benefit. These concepts must be incorporated into nuclear medicine professional training and practice. Along with these efforts, this guidance provides recommendations on the minimum requirements for establishing a radiopharmaceutical-specific quality control testing program.

Comments should be submitted by 15 June 2025.

58th Expert Committee on Specifications for Pharmaceutical Preparations

The following new guidance texts were adopted and recommended for use:-

·         WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products;

·         WHO good manufacturing practices for excipients used in pharmaceutical products;

·         Good practice guidelines for blood establishments;

·         WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms;

·         Guideline on bioanalytical method validation and study sample analysis;

·         Good practices of national regulatory authorities in implementing the collaborative registration procedures for medical products;

·         Collaborative registration procedure between WHO and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified vector control products;

·         Guidance for the graphic representation of chemical structures of pharmaceutical substances in the publications of international non-proprietary names and The International Pharmacopoeia.

Products

[This section makes reference to some of the most notable new products approved during the past month and focuses on approvals of medicines for which there is a previously unmet need and / or where approvals have been made using shared information from other trusted regulators.MBH]

Trastuzumab deruxtecan approved to treat adults with HER2-positive cancer that has spread or cannot be removed by surgery

MHRA has approved trastuzumab deruxtecan (Enhertu) to treat people with solid tumours that have mutations in human epidermal growth factor 2 (known as HER2 positive cancers) that have spread to other parts of the body or cannot be removed by surgery and who have no alternative treatment options. This approval is an extension to the indication (use) of the medicine.

Trastuzumab deruxtecan has been approved through Project Orbis, a global partnership between the MHRA, the Therapeutics Goods Administration in Australia, Health Canada, the Health Sciences Authority in Singapore, Swissmedic, Agência Nacional de Vigilância Sanitária in Brazil and Israel’s Ministry of Health, coordinated by the US Food and Drug Administration. This programme reviews and approves promising cancer drugs, helping patients to access treatments more quickly.

The variation to the marketing authorisation was granted on 9 April 2025 to Daiichi Sankyo UK Ltd.

MHRA approves first UK treatment for Friedreich’s ataxia, omaveloxolone

MHRA has approved omaveloxolone (Skyclarys), the first treatment for patients aged 16 and over, in the UK for a rare neurodegenerative movement disorder Friedreich’s ataxia.

This is the most common type of hereditary ataxia. It is thought to affect at least 1 in every 50,000 people. Symptoms include problems with balance and movement, which get progressively worse over time.

This medicine is taken as an oral capsule.

The new marketing authorisation was granted on 23 April to Biogen Netherlands B.V. This product was submitted and approved via a national procedure.

Marstacimab approved to treat patients aged 12 years and above with haemophilia A or B

MHRA has approved the medicine marstacimab (Hympavzi) to prevent or reduce bleeding in patients 12 years of age and older weighing at least 35kg with haemophilia A and B. This medicine is the first of its kind to work by targeting a protein in the blood clotting process.

This approval is supported by evidence from a main study that evaluated marstacimab in 116 adults and adolescents 12 years and older with severe haemophilia A or B without inhibitors.

The new marketing authorisation was granted to Pfizer Limited.

Obecabtagene autoleucel conditionally approved to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia

MHRA has granted a conditional marketing authorisation for the medicine obecabtagene autoleucel (Aucatzyl), a chimeric antigen receptor (CAR) T-cell therapy, to treat adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL). CAR-T therapy that works by taking a patient’s T cells, and putting them through a process that transforms them into CAR T cells that are able to target the CD19 protein. When put back into the body, these modified cells can recognise and destroy the cancer cells.

This conditional approval is supported by evidence from the FELIX study, an ongoing open-label, single-arm study which enrolled 153 adult patients with relapsed or refractory B cell acute lymphoblastic leukaemia.

The new conditional marketing authorisation was granted to Autolus Therapeutics

Acoramidis approved to treat wild-type or variant transthyretin amyloidosis in adults with cardiomyopathy

MHRA has approved the medicine acoramidis (Beyonttra) to treat adult patients with cardiomyopathy (damage to the heart muscle) caused by variant or wild-type transthyretin amyloidosis (ATTR-CM).

Acoramidis has been approved via a fast-track approval process - the International Recognition Procedure (IRP), following approval by the European Medicines Agency (EMA) earlier this year.

The new marketing authorisation was granted to Bayer plc.

MHRA authorises cancer treatment variation with an administration time of 3–5 minutes

MHRA has approved a new under-the-skin injection version of the cancer therapy, nivolumab (Opdivo), offering a quicker administration option.

The subcutaneous formulation of nivolumab can be given as a 3–5-minute injection instead of the 30- or 60-minute intravenous (IV) infusion. Several common cancers can be treated by nivolumab, including lung, bowel, kidney, bladder, oesophageal, skin, and head and neck cancers. 

Nivolumab is a monoclonal antibody that works by binding to a protein called PD-1 (programmed death-1) on a type of immune cell called T-cells. This blocks cancer cells from switching off T-cells, allowing the immune system to detect and destroy cancer cells.

This product was submitted and approved via national procedure The approval was granted to Bristol Myers Squibb.

Conferences webinars etc.

Sterile substance CEP webinar on 4th June 2025

Due to the increasing interest in certificates of suitability for sterile substances, the EDQM would like to invite CEP holders and users to a dedicated webinar on 4 June 2025. The event will shed light on the certification procedure for sterile substances (including GMP aspects) and also provide an opportunity to share difficulties encountered with interpreting EDQM guidance for sterile substances, with the preparation of CEP applications for sterile substances and with the use of these CEPs once granted.

A presentation addressing the content of a CEP dossier for a sterile substance and the inspector’s and assessor’s viewpoints will be followed by a live Q&A session.

The webinar will be recorded and made available to all registrants shortly after the event, so even if you are unable to attend the live event, EDQM recommend you register all the same!

EMA’s 30th anniversary scientific conference - Medicines, regulation and the future

The EMA’s 30th anniversary scientific conference (Wednesday, 25 June 2025, 09:00 - 15:00 British Summer Time) aims to celebrate three decades of groundbreaking achievements and advancements in the field of medicine and regulatory science.to discuss the latest trends, innovations, and challenges in the field of medicines regulation and public and animal health.

The workshop will be broadcasted live, and the recording will be made available on the EMA website afterwards.

No registration is required to follow the broadcast 

PHSS Sterile Product Conference 2025

This major PHSS conference will address the key challenges in sterile product manufacture and processing of intermediates that require low bioburden control following risk-based initiatives from a regulatory, Pharmaceutical-/-Biopharmaceutical industry, and healthcare pharmacy perspective. AstraZeneca will offer a site tour on the afternoon of June 25th, there will be a networking dinner at Shrigley Hall.

PHSS Annual Conference

This year's PHSS Annual Conference is in association with BioMerieux.

There will be a site tour locally (TBC) and a networking dinner, which BioMerieux is sponsoring.

The conference day on the 17th of September, is packed with keynote speakers, industry SME, and MHRA (TBC).

PHSS - QP Forum Conference 2025

The Conference is designed for all QPs and aspiring QPs. Listen and interact on topics and the latest developments regarding the duties and responsibilities of QPs.

This annual event has proved valuable to those in the QP role.

And finally…

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.

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.

GMP Update is compiled by Malcolm Holmes C.Chem. MRSC, a member of the PHSS Management Committee.