Regulatory guides: Life sciences

Drugs. Medical devices. Diagnostics. Developers of these innovations in the life sciences sector need to be aware of the regulatory requirements of product development. These regulatory guides, designed for the non-regulatory affairs professional, provide high-level information about the different aspects of regulatory affairs.

We have provided information on the following four topics:

• Clinical trials
• Drug marketing: Application process
• Medical device marketing: Application process
• In vitro diagnostics

We have also prepared two additional documents to help entrepreneurs and researchers guide their product development:

• The regulatory strategy document outlines the key aspects of a regulatory strategy and the necessary components.
• The  International Conference on Harmonisation (ICH) Guidelines article summarizes the key aspects of ICH (a joint initiative to increase the international harmonization of technical requirements to ensure that safe, effective and high-quality medicines are developed in the most efficient and cost effective manner), including where to find the guidelines and what they cover.

More detailed information about regulatory affairs can be found on the websites of regulatory agencies around the world, notably those in Canada, the US and Europe. Links to these websites are provided in each document.

Tags: drug-development, life-sciences, medical-devices, regulatory-approval