Regulatory Strategy Analysis
Clinical trials have been performed at many sites around the world for many years to obtain approvals in multiple countries. The harmonization of regulatory processes developed by the ICH, drug patent laws, and country specific regulations is very important steps towards the product development, such as drug discovery, early development and preclinical testing, clinical trials and marketing authorizations. Nearly every country agrees to accept the ICH technical necessities for registration of pharmaceutical products for human use. Taking this into an account makes very easy to perform worldwide clinical trials by outsourcing and offshoring models to achieve the numerous regulatory and commercial incentives obtainable in many countries. The perfect time to build a regulatory strategy is before submitting an Investigational New Drug (IND) application. Pre-IND meeting also requires submitting a development plan with the meeting documents. The format of the strategy documents depends on the company, its culture, and the past experience of regulatory submission needs to be included in the final document. A strategy document is an organized combination of all the sides of the drug development from pre-IND to the NDA and up to product commercialization approved by several stakeholders. The document is an excel spreadsheet or a working “book,” it must capture and documented any changes to the …show more content…
There are many specific application procedures depending on where you want the license:
Decentralized Procedure can be used to get marketing authorization in the UK and other EU countries.
Mutual Recognition Procedure can be used if a company have a national license in 1 or more EU countries but want to marketing authorization in other