Post-Brexit, the biggest challenge for the pharmaceutical industry is its potential implication on Regulatory affairs. The derogation as a result of post-Brexit is expected to hit the pharmaceutical industry extremely hard, especially the Pharma companies operating in the UK. Therefore, a careful evaluation of the political situation and Regulatory framework is necessary to learn the consequences. The negotiation between the parties, regarding the future relationship, must be concluded as soon as the end of the transition period begins, which may in turn lead to any of the following scenarios:
- European Economic Area (EEA) - Free trade services within the European internal market
- European Free Trade Association (EFTA) - Free trade and economic integration between its member states across the globe
- World Trade Organization (WTO) - In case of a no-deal, the government has to set out its trade agreements based on 'WTO rules'
There is still hope that these negotiations might lead to contractual arrangements of mutual recognition related to many drug Regulatory aspects. However, companies must not underestimate the risk of having a no-deal and should start focusing on the following key areas and be prepared for any outcome:
- Marketing authorizations and drug approval procedures
- Good Manufacturing Practice (GMP)
- Quality of pharmaceutical products
- Clinical trials
Recommended Actions for Pharmaceutical Companies:
Here's the list of suggested activities for the companies to be prepared for any of the Brexit outcomes:
- It is highly recommended to be in contact with the relevant Health Authorities (i.e., EMA and MHRA) proactively and seek advice regarding the Regulatory updates.
- A cross-functional Brexit Working Group must be established within the company that includes drug Regulatory subject matter experts, representatives from the impacted sites and departments such as legal, manufacturing, artwork management, clinical development, drug safety and quality.
- Effectively coordinate for marketing authorization transfers, orphan drug designation transfers and variations.
As Brexit is now a reality, it is suggestible for Pharma manufacturers to be ready for any situation. By all the Regulatory means, they should be equipped for compliance. There is a little time for transition. Act now! Stay informed. Stay compliant.