Mutually beneficial — worksharing makes pan-Atlantic product launches easier

One of the potential pitfalls when preparing a product launch is planning for GMP inspections. An upside of recent events, the FDA confirming that eight EU member states have at least equivalent capabilities as the FDA in performing GMP inspections, is worksharing, leading towards a more globalised market. In this article Vikash Patel, senior regulatory specialist for ELC Group, tells us more…

Most drug development teams know that apart from the various internal mechanisms that need to be navigated before product launch, there are obviously many external regulatory-driven mechanisms to steer through. One of these potential pitfalls is planning for GMP inspections, so as to ensure that the majority of markets are covered in the first wave of submissions, as well as subsequent markets that accept mutual recognition, normally wave two and three markets covering ROW territories.

The good news is that, as of 1 November 2017, the FDA has confirmed that eight EU member states have at least equivalent capabilities as the FDA in performing GMP inspections. This is a historic first, since to date all companies wishing to launch products in the US and EU needed to plan separate inspections from both the FDA and an EU member state.

The EMA had already confirmed back in June 2017 that the FDA had the equivalent capabilities with regards to GMP inspection, so this recent reciprocation from the FDA is a welcome move and allows much closer cooperation and worksharing between the bodies.

There are many upsides to this latest move by the regulatory bodies to improve on working collaborations, one of which is a consistent view of GMP, enabling a much more streamlined approach by companies to plan for their inspections. It has been well documented that, hitherto, many manufacturing plants have had to run two separate programmes to cater for EU and FDA inspections.

Additionally, technical and quality teams from individual companies can now start working towards a better harmonisation of systems and resource planning, as well as dialogues with the inspectorate. The EMA has issued a press release to give further background to this latest development,¹ and it is clear to see from this that regulatory bodies are increasingly working towards a more globalised market.

Inspection planning can be all too often rushed and left to the last minute; however, with these changes being brought about by the competent authorities, there has never been a better time for companies to become more proactive with their strategies with regards to site of manufacture as well as inspection preparation.

The expectation is that there will be further expansion of such worksharing between authorities, including GMP guidelines and directives. As this worksharing is just in its initial official phase, there will naturally be more questions than answers regarding already planned and agreed inspections as well as supporting documentation changes to support FDA and EU submissions.

It is imperative for regulatory divisions to maintain a watchful eye on these developments and contact the competent authorities to ensure correct procedural understanding if intending to take advantage of this new worksharing agreement.

Reference:

http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2017/10/WC500237909.pdf