Regulatory

The regulatory process is not only necessary but also the sufficient condition for any pharmaceutical product to (legally) enter any market globally. The different national systems vary greatly and the regulated markets apply significant time for a product to enter the market whether they are NCEs or generic products. The timelines of the different regulatory processes are highly differentiated and vary from a few months to several years. Detailed insights of the individual markets are therefore decisive for fully understanding the market timing of individual products.

The most complex regulatory system today is the EU regulatory system, as it comprises 29 individual national systems with varying degrees of EU harmonized systems. The most extreme case is for generic approval options. Any generic (if excluding biosimilar products) has four different routes of applications: National Registration Procedure (NRP), Mutual Recognition Procedure (here a NRP is required), Decentralized procedure, and the Centralized Procedure – each one with significantly different approval timelines. In addition, they may choose between five different (excluding the bio-similar legal basis) legal bases (10.1: straight generic application, 10.a: well established use/bibliographic application, 10.b: fixed combination application, 10c: informed consent application, and 10.3: hybrid application). The end result is differences in regulatory timelines of up to years depending on the choice of route and legal basis and is thereby a central element in appreciating any generic launch in EU.

Our clients have direct access to our regulatory timeline calculator, through the restricted client section of our website, providing calculated regulatory timelines (based on average timelines of the 50 latest approvals in each category) for all regulatory procedures in the EU, the US, CIS, China, India, Korea, and Australia. Our contacts are free to inquire on a case-by-case basis on the timelines for the different regulatory geographies and procedures.