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

EJPPS vol 30.1A 


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 and Australian regulatory authorities. 

 

UK 

Medicines and Healthcare products Regulatory Agency (MHRA) 

  • MHRA trials five innovative AI technologies as part of pilot scheme, AI Airlock, to change regulatory approach  

  • MHRA warns against buying weight loss medicines without a prescription this New Year  

 

EU 

European Medicines Agency (EMA) 

  • 3-year rolling work plan for the Quality Innovation Group (QIG) 

  • Mid-year report 2024 

  • Guidance for industry on implementing Shortage Mitigation Plans (SMP) 

  • Quality of medicines Q&A: Part 1 

  • DRAFT Qualification opinion for Artificial Intelligence-Based Measurement of Non-alcoholic Steatohepatitis Histology in Liver Biopsies to Determine Disease Activity in NASH/MASH Clinical Trials 

  • Frequently asked questions about parallel distribution 

  • Highlights – Seventh EMA- EFPIA bilateral meeting 

  • Highlights – 3 rd EMA-EUCOPE bilateral meeting 

  • ICH Q4B(R1) Guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions- Step 5 

  • EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO) 

  • 2024 achievements in medicine regulation 

  • Guidance on GMP & GDP Q&A 

  • Q&A on the Union list of critical medicines 

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

  • New FAQ on EDQM: system suitability test in assay chromatographic procedures  

  • European Pharmacopoeia Supplement 11.8 now available 

  • New addition to the work programme of the European Paediatric Formulary  

  • European Drug Shortages Formulary project: approval of framework and procedure documents  

  • Collaborative study on validation of an ELISA method for determination of physical particle titre of AAV2 vectors 

  • Brazilian health authority to rely on CEP evaluation procedure  

  • reference standards 

 

Ireland  

The Health Products Regulatory Authority (HPRA) 

  • Public consultation on development of the HPRA’s 2026–2028 Strategy 

  • New Veterinary Regulation - Update December 2024 

 

USA 

The US Food and Drug Administration (USFDA) 

  • Accelerated Approval – Expedited Program for Serious Conditions  

  • Advanced Manufacturing Technologies Designation Program  

 

International 

Australia 

Therapeutic Goods Administration (TGA) 

  • Recall reforms update and new procedure 

Products 

  • MHRA-Delgocitinib approved to treat adult patients with moderate to severe chronic hand eczema  

  • MHRA - conditional marketing authorisation for the medicine givinostat (Duvyzat) to treat Duchenne muscular dystrophy (DMD).  

  • MHRA - Tarlatamab approved to treat adult patients with small cell lung cancer  

  • MHRA - Sotatercept approved to treat adult patients with pulmonary arterial hypertension (PAH)  

  • First treatment for peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome 

  • First treatment recommended for rare progressive lung conditions in children and adolescents 

Conferences 

 

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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