Pharmathen - The pros and cons of post-authorisation studies

Under European guidelines, all pharmaceutical products receiving or maintaining a marketing authorisation must go through a risk management plan that considers the safety and efficacy of the drug after it has been authorised and made commercially available. Pharmathen considers whether these post-authorisation studies are a burden or an opportunity for industry sustainability.


In 2012, the first independent committee responsible for monitoring and evaluating the safety profile of medicinal products authorised in the EU was created at the European Medicines Agency (EMA), known as the Pharmacovigilance Risk Assessment Committee (PRAC). The activities of PRAC serve the scope of improving the promotion and protection of public health by evaluating and minimising safety risks.

PRAC's responsibilities include enhancing the compliance of the pharmaceutical companies with the new requirements of the Pharmacovigilance legislation, reviewing risk management plans (RMPs) and assessing the periodic safety update reports (PSURs). Indicatively, PRAC's recommendations have already resulted in changes to more than 50 products authorised in the EU. Pharmaceutical products such as codeine, ketoconazole and strontium have 'suffered' severe restrictions in their use.

Evaluation
It is worth considering that, according to European guidelines, the implementation of post-authorisation safety (PASS) and efficacy studies (PAES) as part of an RMP is a requirement for all pharmaceutical products receiving or maintaining a marketing authorisation. Post-approval studies can either be interventional or non-interventional investigations that evaluate the effectiveness and safety of drugs in the routine clinical settings, instead of the controlled environment of the pivotal clinical trials that were used to receive the marketing authorisation. The PRAC is responsible for evaluating and approving the PASS protocols and results.

One of the areas that shows the determining role of PRAC on the authorisation of drugs includes biosimilars. The recent guidelines/proposals of the EMA and FDA show a tendency by authorities to proceed with the approval of such products by focusing on quality studies, rather than extensive clinical programmes. However, a strict pharmacovigilance plan, which includes but it is not limited to immunogenicity studies and product-specific reporting, is mandated.

In addition, the recently published guidance by the EMA demonstrates the need for an enhanced surveillance system as part of the RMP of any seasonal influenza vaccine. The enhanced surveillance can take the form of either an active (PASS) and/or a passive pharmacovigilance monitoring. The purpose of performing an active surveillance is to facilitate the rapid detection of clinically significant changes in the frequency and severity of already known adverse drug reactions, which can further signal serious side effects as vaccine exposure increases.

Financial ceiling
In some cases, one may consider that PRAC creates a financial ceiling related to the clinical development of a medicinal product required for obtaining a market approval. Stated differently, the implementation of post-approval studies which comprise the RMP of newly authorised products gives the opportunity to the pharmaceutical companies to transfer the costs of R&D to the post-market surveillance, hence allowing the costs to be complemented from the market share of the product. Therefore, the current situation with the enhanced function of PRAC strengthens the flexibility of the pharmaceutical companies with respect to the financial burden of drug development.

This can be of a great importance considering areas of unmet medical needs such as the orphan drug market, in which the pharmaceutical companies face huge costs of development and limited sales. Approximately 87% of drugs authorised for orphan conditions required post-approval studies. For example, EMA recently approved a beta-blocker for an orphan condition affecting the infants based on the RMP that included PASS to investigate the long-term safety of the product and a drug-use study to evaluate the off-label use of the drug.

To conclude, PRAC's activity can be perceived not only as a promoter of public health protection, but also as a tool for enhancing the sustainability of the pharmaceutical industry.

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