How Regulatory Affairs are Changing In Pharma Industry

R&D - clinical phase: setting up the right clinical development strategy

Initially in the development phase, specifically at the research stage, it is highly crucial for getting regulatory affairs that are involved for ensuring that an appropriate Clinical Development Strategy is developed with the aim of a carefully planned series of clinical trials, that ranges right from first-in-human Phase I - Phase II POC & crucial Phase III trials for the purpose of registration.

Although Clinical trials are highly expensive & can consume several years to complete, their outcome to demonstrate the efficacy of the drug candidate is inherently uncertain. If a pharmaceutical firm delays in either completing or discontinuing a clinical trial of its drug candidates, not just the commercial prospects of the drug candidates will be harmed but also the ability to generate revenue from any of these drug candidates will be delayed.

The Investigational Medicinal Product Dossier which comprises Chemical Manufacturing & Control data are a highly crucial part of the Clinical Trial Application. The regulatory affairs teams will come up the quality sections of the Investigational Medicinal Product Dossier with a phase-appropriate level of detail. Though the EMA renders guidance to the industry on the anticipated content for an Investigational Medicinal Product Dossier for either chemical-based products, biological products, or even ATMPs, an experienced CMC writer should be rendering the exact level of detail in the Investigational Medicinal Product Dossier for the clinical process in which the investigational product is presently at.

In the case of complex developments or even innovative technologies, RA experts will have to look for scientific advice from either the national competent authorities or even EMA via a particular procedure in order to ensure that the development as well as future registration of the dossier proceed as per the agreed anticipations of the regulators.

Marketing Authorization Application

After the successful clinical process, a firm wants to get the regulatory approval for the medicinal product, however, the regulatory approval phase of the competent authorities is not just lengthy, but also time-consuming & inherently unpredictable.

Therefore, as a result, the role of experienced regulatory affairs team in the process of approval will be crucial for maintaining the aim of timely commercialization of the product. Understanding that a medicinal product may either be marketed in the EU only when a Marketing Authorization has been allowed by the European Commission through centralized procedure or even the competent authority of members states through National Procedure, the Mutual Recognition Procedure/Decentralized Procedure.

Pharmaceutical firms should decide on the submission strategy of the marketing authorization dossier while they are applying for the Marketing Authorization application.

Therefore, an applicant should be carefully considering all logistical as well as regulatory issues before submission and a key source for input as well as implementation throughout the decision-making task will be the regulatory affairs team, that will need to estimate.

In a nutshell

The role played by Regulatory Affairs in the pharmaceutical sector is substantial and this helps in ensuring the successful development as well as commercialization of a medicinal product, that is crucial for involving the regulatory experts in all phases of development, right from the early phase of the clinical trial to post-approval changes during the product commercialization too.