The Poor Relation in Drug R&D—Chemistry, Manufacturing and Controls

What about the SARS-CoV-2 injections supply chain?

So, What is Chemistry, Manufacturing and Controls?

First off, and with apologies to those who already know this, we start with the basics. Drugs are regulated by a designated competent authority known as a Regulatory Authority. In the United States, the Regulatory Authority is the Food & Drug Administration (FDA).  In Europe, the Regulatory Authority is the European Medicines Agency (EMA).  In Japan, the Regulatory Authority is the Pharmaceuticals and Medical Devices Agency (PDMA).  

Regulatory Authorities principally approve drugs for clinical trials and sale, inspect and license organizations and facilities for suitability to operate in the drug industry, and monitor the safety of medicines. Regulations are laws, not nice to haves. Remediation of a breach is legally enforceable and may lead to prosecution. In the US it is the Federal Food, Drug, and Cosmetics Act, first passed in 1938, and Title 21 of the Code of Federal Regulations.

Similar legislation is in place in the EU under various EU Directives. The original directive title is DIRECTIVE 2001/83/EC. There have been various amendments since to be found on the Eurpoean Medicines Agency (EMA) website. UKs MHRA has to follow all EU Directives, even though it has left the EU, since this is required to allow UK based pharmaceutical companies to sell into the EU.

Chemistry, Manufacturing and Controls is one of three modules that must be submitted to a regulatory authority for review and evaluation, prior to a decision to approve or reject the application.