Your top-notch strategic advisor – regulatory authorities!
Regulatory authorities; national authorities, EMA or FDA are the best regulatory advisors. Not only because they have a vast experience from evaluating a range of products in different development phases, but because at the end of the day; they decide which drugs make it to the market.
Our philosophy is that it is better to investigate what regulators really want to see rather than guessing and ask them sooner rather than later. A common advice when working with us in SDS is therefore to prepare early for authority interactions. Now you think, this sounds fabulous! No regulatory consultants needed, let’s ask the Medical Products Agency instead. Yes, there is a fee of 45 kSEK – but that’s still a good deal compared to lengthy work with regulatory consultants. So, what is the catch? The short answer is that you get the answers you deserve based on your own efforts.
So, what is our best advice on how to get the most out of an interaction with regulatory authorities?
-You need to decide what is the primary objective with the planned meeting? Maybe you don’t have any “real” questions but need the blessing of a regulatory authority to get support from investors? Or do you have real strategic questions where you need guidance to make the right choices with regards to CMC- preclinical or clinical development? Regardless of your motives; you need to have your objectives in focus when planning the meeting.
-Which regulatory authority should one contact? Drug development projects usually aim for a multinational market right from the start. It is not obvious that one should contact the closest regulatory authority. Some of the questions to consider are the complexity of the advice needed – agencies have their individual profile, and some are stronger within certain disciplines than other. Other aspects to consider, especially for late phase project is the planned submission strategy. Common authorities to consider for your advice are different national authorities (eg. MPA or German authorities BfArM), EMA or the FDA.
-An authority meeting typically last 1.5 hours – an FDA meeting usually 1 hour. You don’t have time to discuss everything – you need to cherry-pick your critical questions. Choose the aspects where authority input really matters and where the answer has true value and impact on your development plans.
-Generally, authorities don’t answer open-ended questions. (Sometimes with a good portion of luck it is possible to pose an open question in the meeting, but don’t count on that!). This means you need to answer your questions yourself and present the answers to the regulatory authorities. Your “answers” are called Positions.
-Your position is your opportunity to convince regulatory authorities that your ideas are good and should be supported. Imagine you have a good rationale for why a slim safety package should be accepted as sufficient prior to phase I or you want to convince regulators to accept a novel endpoint for a pivotal study? This is your chance to present you solution to the challenge and have regulatory blessing.
-There may be questions you may not want to ask. Maybe you cannot build a sufficiently strong position to support your point of view – yet. Then maybe you should postpone that question for a later time point rather than risking regulatory push-back which may create an unnecessary uphill.
This is of course not an exhaustive list – planning for valuable interactions with regulatory authorities is a life-long learning process. To get the most out of a planned meeting you need to prepare meticulously and to work with a regulatory affairs professional that can guide you through the maze of regulatory do’s and don’ts. Are you interested to hear how we at SDS can help you plane for a successful authority meeting? Give us a call!