Last week’s round-up, 17-21 February 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud


Everyone’s a Critic: FDA Under Fire for High Drug Approval Numbers

21 February 2020

The FDA has recently been criticized for the high number of novel drug approvals granted in 2019.

A study carried out by Harvard Business School, the University of Texas at Dallas, and the MIT Sloan School of Management, has found that the highest number of drug approvals in the US occurs in December and the week before Thanksgiving. The study found that these ‘December drugs’ are associated with significantly more adverse events than drugs approved throughout the rest of the year, and the authors suggest that these ‘rushed’ approvals could be subject to more lax reviews.

The FDA Law Blog article below provides an interesting analysis of the results and various hypotheses found in the study and suggests that the study authors underestimate the rigorous risk/benefit analysis behind each drug approval.

CMDh updates

20 February 2020

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has released the following updates:

  • An updated Chapter 1 of the Best Practice Guide for the allocation of the Mutual Recognition variation number for Type I notifications, Type II variations, grouping and worksharing.
  • The minutes and presentations from the 13th November 2019 meeting with representatives of interested parties. The topics discussed include: the results of the 2019 AESGP Survey on MRP-DCP for non-prescription medicines; multilingual labelling practices across Europe; Brexit-related RMS changes; the Best Practice Guide on Multilingual Packaging; and the Harmonisation of RMP Project (HaRP); the CMDh project to harmonise risk management plans (RMPs) of products with the same active substance.
  • An updated “Blue-Box” requirements document.
  • An updated CMDh annotated QRD template for MR/DC procedures document.

European Regulators Strive to Make Up for Lost Ground

19 February 2020

European regulators are expected to be more active in 2020, striving to make up for ground lost in recent years due to Brexit.

The regulatory agendas of the EMA and national agencies are expected to be dictated to a certain extent by the new European Commission’s priorities. In healthcare, these include patients’ access to innovative drugs, affordability of medicines, combatting medicines shortages, encouraging digitalization in health services, ensuring effective oversight of the global supply chain, and greener manufacturing. The EU’s network of agencies will be working to finalize Europe’s strategy on regulatory science to 2025, which should be published in October.

Results of an EMA investigation into the nitrosamine situation will also be revealed by the middle of this year, which may lead to a further tightening up of EU rules relating to the quality of imported APIs:

European Pharmacopoeia updates

18 February 2020

The European Pharmacopoeia (Ph.Eur.) has released the following updates:

  • In all monographs, the names of reagents used to describe the stationary phases for LC and GC columns have been reviewed to ensure clarity and consistency in the description of stationary phases.
  • Withdrawn reference standards will continue to be sold for 6 months after their official withdrawal date and will remain in the catalogue for 12 months to allow for the printing of Batch Validity Statements (BVS) and/or finalising of the necessary procedures for controlled substances.
  • The European Committee for Food Contact Materials and Articles (Partial Agreement) has released two new provisions for consultation.
  • CEP users may provide comments on the draft monographs published in the Pharmeuropa 32.1 until the end of March 2020.
  • The Ph.Eur. has revised the general chapter on the degree of coloration of liquids and it now also includes the instrumental method. The revised chapter will be available in the Ph.Eur. Supplement 10.3 in July 2020.
  • CEP holders are invited to update their applications according to the revised monographs released in the Ph. Eur. Supplement 10.2.

Pharma industry calls for GMP agreement between EU and UK

17 February 2020

The pharmaceutical industry has called for a Mutual Recognition Agreement (MRA) on good manufacturing practice between the EU and the UK.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), Medicines for Europe, and Association of the European Self-Medication Industry (AESGP) have issued a joint statement, highlighting this as a critical recommendation which would help to secure continuity of supply of medicines in both markets and free up agency resources.

The organizations have stated that, “As the UK has been an integral part of the EU regulatory system for several decades, and given that the current UK and EU legal framework is the same, this should be a comprehensive MRA that encompasses inspections by European inspectors within the European Economic Area (EEA), MHRA inspections of UK sites, inspections that both European and UK inspectors conduct outside the UK and EEA, as well as batch testing”:


Image: Pills and capsules of different colors. Top view, CC BY 2.0

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