IPEC e-newsletter - Excipients Insight January 2018 - 20-01-18


Inside this issue


2018 set for big changes in pharma regulation

As 2017 drew to a close, the director of the European Medicines Agency (EMA) – Professor Guido Rasi – predicted that 2018 will a challenging year for the regulator and the industry it serves, not least because of Brexit and the resulting relocation of the EMA from London to Amsterdam.

The move and preparing for the UK’s withdrawal from the EU “will occupy the time of many staff members that we would rather spend on activities that make a difference to public health,” he said, adding that this will inevitably lead to refocusing of core tasks and adjournments for some initiatives. Questions still remain about the role of the UK Medicines and Healthcare products Regulatory Agency (MHRA) and impact on regulatory approvals. Notably, around 200 of EMA’s 900 staff in London have suggested they will not be staying with the agency after the transfer.

A recent article in Pharmaceutical Technology notes for example that the UK “not only has the EU’s second highest number of GMP and other medicinal manufacturing sites but the third highest number of batch certification sites. Replacement batch release sites in the EU/EEA will have to be set up with qualified personnel.”

Nevertheless, the day-to-day work of the EMA has continued, and 2017 saw a number of regulatory developments in the area of Good Manufacturing Practice (GMP) that will come to fruition in 2018 and beyond.

Towards the close of the year the EMA introduced major changes to Good Manufacturing Practice (GMP) for the manufacture of sterile drugs with revision to Annex 1 its GMP guide for these products with a number of changes including the introduction of Quality Risk Management principles, with the World Health Organization (WHO) and the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) contributing to the update.

It seems that we have been talking about ICH Q3D Elemental Impurities for years – because we have – and as of 1 January this year a series of requirements and revisions to the guideline have come into effect, notably including General Chapter 5.20, the General Monographs on ‘pharmaceutical preparations’ (2619) and ‘substances for pharmaceutical use’ (2034) and general method 2.4.20 on ‘determination of elemental impurities’.

2017 also saw the introduction of a new and longer EU GMP guideline for investigational medicinal products (IMPs) and accompanying delegated regulation, taking into account new Good Clinical Practice (GCP) requirements in the 2014 Clinical Trials Regulation, and the removal of sections on IMPs from the current GMP directive 2003/94/EG which is being replaced by the new GMP Directive 2017/1572 that only covers commercial products.

The year also saw the publication of a GMP guideline for advanced therapy medicinal products (ATMPs) such as cell-based and gene therapies, which comes into effect on 22 May. These therapies offer ground-breaking new opportunities for the treatment of diseases and injuries and are particularly important for severe, untreatable or chronic diseases for which conventional approaches have proven to be inadequate.

There were other developments of note in the 2017. In November, a mutual recognition agreement that will allow regulators in Austria, Croatia, France, Italy, Malta, Spain, Sweden, the UK and the US to share inspections data came into effect. Other EU member states will be added as soon as their evaluation by the US FDA is complete, although the European Compliance Academy (ECA) notes there are some issues still to tackle, including differing approaches to the routine inspection of IMPs between the US and EU and in the issuing of GMP certificates.

Finally, it’s worth pointing out that 2017 was something of a landmark year in terms of new therapies making their way through development and regulatory review, which is being taken as a positive sign for the overall development and health of the industry.

The EMA approved 92 novel and generic drugs, while the FDA cleared a record 46 new molecular entities. The year saw the approval of the first chimeric antigen receptor T-cell (CAR-T) therapies for blood cancers as well as the US’s first gene therapy, leading analysts to predict rosy prospects for the biopharma sector – provided it can work out how to price them at a level healthcare systems can afford.




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