Regulations in the Pharmaceutical Industry
It is difficult to overstate the importance of regulation in the pharmaceutical industry. Even the drugs that are approved could have some side effects, some serious (a good example being chemotherapy drugs used to treat cancer), and it therefore follows that drugs that have not been tested and approved by regulators could lead to fatality. The approval of drugs by regulatory bodies is a must in most parts of the world. Note that most of the leading pharmaceutical companies such as Pfizer, GlaxoSmithKline, Sanofi-Aventis, AstraZeneca, Hoffmann–La Roche, Johnson & Johnson, Merck & Co. and Sanofi do their own tests and clinical trials.
Regulation is done by the pharmaceutical industry associations and by government regulatory bodies. Industry associations that do regulation include the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), the Drug Information Association (DIA), and the European Federation of Pharmaceutical Industries and Associations (EFPIA). In the EU, the major regulatory authorities are the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use or ICH and the European Medicines Agency or EMEA. If you are buying drugs from outside the EU, ensure that they have been approved by the relevant regulators who include the Therapeutic Goods Administration (TGA) in Australia, the Food and Drug Administration (FDA) in the U.S. and Ministry of Health, Labour and Welfare in Japan.
Regulation not only ensures that the drugs manufactured are safe for human consumption but that they also cover patent expiries and the tightening healthcare budgets. Most pharmaceutical companies have dedicated regulatory departments and they often outsource the service to regulatory affairs consulting firms to ensure that their drugs go through. Note that the pharmaceutical industry also manufactures medical devices and these too are regulated. Regulators release guidelines that pharmaceutical companies have to follow in the drug and medical device pipeline and they handle complaints from the public.