Improving Regulatory Procedures for Medicinal Products in Europe

What we have in place in Europe already provides an excellent means for bringing products to market. Many would consider the Centralised Procedure, which was first introduced in 1995, the ideal route for approval within Europe. Since 2005 the Centralised Procedure, coordinated successfully by the European Medicines Agency (EMA), is now a valid route for many Consumer Health products, biosimilars and generics. It has a number of advantages for the companies that use it, the regulators and for public health; allowing simpler and perhaps better regulation of medicines, easier and better distribution once a product has been approved for companies, as well as a better supply chain and improved pharmacovigilance .

Whilst the Centralised Procedure works very well, obtaining approval in Europe is now slower than in the US and sometimes slower than markets such as Japan. This is due to the legislation and the requirement of the Commission’s involvement in the decision making process which results in applications taking around fifteen months to complete. It is the preferred system for many organisations but would be even more attractive if submissions could be reviewed faster.

The EMA’s ability to approve applications is dependent upon the available capacity of the Committee for Medicinal Products for Human Use (CHMP) for reviewing submissions. It would not be feasible for everyone to use the Centralised Procedure working to current processes. However focusing more on complex assessments and less on straight forward applications could provide a way forward within the CHMP to address such an issue and improve efficiency.

Granting conditional approvals could also be an effective way to speed up this process whereby medicinal products are given approval based on an initial review of positive clinical data and then given full approval once a complete review of all the data has been undertaken (studying its effectiveness following use over a period of time). This is currently used much more effectively in the US than it is in Europe.

Finally, another innovative solution to improve the European approval process could involve creating a product monograph as a mirror for the branded medicinal product to deal with all the generic applications once its ten year period of exclusivity ends. This could be implemented via a system where the products can be placed on the market and a report is submitted every six months to say what has been marketed during that period.

However effective the Centralised Procedure is or can be, companies will always need to be able to justify the costs associated with obtaining approval in all of the EU Member

States, if they only plan to market the product in one or two states this will still not be the best option.

TRAC is a regulatory affairs consultancy created in 2001 by Jonathan and Sarah Trethowan. We help pharmaceutical companies meet the regulatory requirements needed to market and sell their products within Europe. For a medicine to be marketed it needs to meet certain standards of quality, safety and efficacy set by governments and authorised by national regulatory bodies. We work with companies across the pharmaceutical, biotechnology, medical device and healthcare industries. Read more about the Centralised Procedure mentioned in this article. Our industry experts can also support you with all aspects of the Pharmacovigilance system and safety reporting. To find out more visit www.tracservices.co.uk .