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Reg Affairs
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Regulatory affairs
Dr. Parvinder Punia.
This issue’s contribution has been provided by Dr. Parvinder Punia, senior regulatory expert, EU and related markets, at pan-European regulatory affairs organisation ELC Group. With a decade of regulatory experience — which included roles in two EU health agencies — Dr. Punia is an RA expert in the EU and other regulated region procedures. Responsible for managing worldwide submissions, she has expertise in regulatory strategy development, budgeting preparation and scientific and regulatory documentation. From dossier preparations and conversions for devices and medicines, she regularly employs her extensive working knowledge of European licensing procedures (mutual recognition and decentralised). Her background includes working as a project manager at the National Authority of Medicines and Health Products (INFARMED, I.P.) in Portugal and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.
When the decentralised procedure (DCP) was implemented in 2005, I was employed by an agency. It was a time of great change in the EU directive and a sense of anticipation accompanied its introduction. Previous to this, there were only two possibilities: the centralised procedure (CP) or the national procedure (followed by mutual recognition). The system had required an overhaul and a new perspective. The DCP changed the way the EU introduced new medicinal products. The basic premise is that if an MA does not exist anywhere, a new application can be filed simultaneously to multiple member states. They will then simultaneously evaluate the application and grant approval at the same time. The concept of the reference member state (RMS) and concerned member state (CMS) from the mutual recognition (MR) was carried over to the DCP. This allowed flexibility without the associated costs of the CP.
In the early days, there was a significant amount of experience gathering to be done. The Coordination Group for Mutual Recognition and Decentralised Procedures — Human (CMDh) began working to iron out any flaws noted in the procedure and, to this day, continues to evolve to improve the DCP. However, at the beginning, only a few agencies were active as RMS. Germany, the Netherlands, the UK and Denmark dominated as RMS in the early years, then after 2010, other agencies — significantly Portugal and Sweden — also contributed to the RMS work. These six agencies remain the most active today, although all agencies have now participated as RMS in a DCP.
Another significant change that came about with the DCP was the referral system. The DCP has served to highlight the large discrepancies in expert opinions within the EU, and previously these would be referred automatically to the Working Party (WP) or Committee for Medicinal Products for Human use (CHMP) for resolution. Now, a versatile interim has been provided and utilised extensively, where 60 days are given after the closure of a DCP for agencies to discuss such matters. This has resulted in a reduced burden of work being passed to the CHMP and increased awareness of technical issues amongst agencies. Additionally, such discussions have resulted in a proactive approach to harmonisation of summaries of product characteristics (SPCs) in the EU, as the procedure is well-used by the generics industry.
There are still areas for improvement, for example, the national phase after the DCP approval that could benefit from the same examples set by the procedure itself. Other areas that could be improved are the active substance master file (ASMF) assessments and GMP inspections. However, it is noted that all these aspects and more are being reviewed and work is being done to include these in the DCP.
The CMDh continues to work tirelessly in order to keep the high standard that the DCP has already set. As well as being in control of procedural aspects, it is also involved in ensuring that all aspects run smoothly. This includes, but is not limited to, respecting timetable timelines, managing referral processes, bridging the gap between industry and agency, consulting with EMA experts to gain experience and opinions, interpretation of legislation and guidelines and harmonisation as well as being available for all matters of consultation and public speaking events. The CMDh has been at the core of the success that has followed the DCP until today.
Having seen the DCP from three perspectives — agency, industry and consultant — my opinion is that the EU can boast the highest level of marketing authorisation application (MAA) coordination not yet seen in any other regulated region. It could be used as an example of how different languages, opinions and histories can work together towards a uniform regulating procedure.