The significance of pharmaceutical regulations
Why do we need a strong framework of pharmaceutical regulations?
Drugs cannot be characterized as ordinary products, since in most of the cases the consumers are not in the position to decide about which drugs to use, when and how to use them or to weigh the pros and cons regarding their safety and efficacy.
Due to sophisticated scientific issues related to medicines, healthcare professionals may also not have the right medical training to advise the consumers appropriately .
Thus, Governments, in a mission to protect and promote public health, need to establish strong national regulatory authorities (NRAs), to ensure the safety, quality and efficacy of pharmaceutical products.
Pharmaceutical regulations are defined as “the combination of legal, administrative, and technical measures that governments take to ensure the safety, efficacy, and quality of medicines, as well as the relevance and accuracy of product information” .
Which are the principal pharmaceutical regulatory functions?
Effective regulation of drugs requires a variety of functions and includes a wide range of several mutually reinforcing activities. Regulations vary from country to country in scope and implementation, but generally they concern the following actions :
- evaluation of safety and efficacy data from animal and clinical trials,
- licensing and inspection of manufacturing facilities, import, export, distribution channels, promotion, and advertising of medicines,
- assessing the safety, efficacy, and quality of medicines, and issuing marketing authorization for individual products,
- inspecting and surveillance of manufacturers, importers, wholesalers, and dispensers of medicines,
- controlling and monitoring the quality of medicines on the market,
- controlling promotion and advertising of medicines, to assure that safety and efficacy claims are accurate,
- ensuring the continuous monitoring of medicines once they have entered the market, in order detect potential safety and quality issues,
- providing independent information on medicines to professionals and the public.
Towards a global regulatory convergence
In recent years, we are moving towards the globalization of pharmaceutical issues, aiming in aligning regulatory requirements across the world and gradually uptaking internationally accepted/recognised technical and procedural standards and principles .
This procedure brought changes in international trade, patent protection and pricing and has resulted in several initiatives that must be considered by countries developing pharmaceutical regulations. Such initiatives are the TRIPS Agreement, the International Conference on Drug Regulatory Authorities, and the International Conference on Harmonisation.
The EU regulatory system for medicines
The EU has developed a standardised system of rules and harmonised procedures regarding the authorisation of medicines and the supervision of the medicines’ safety, which apply to all its Member States.
The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA.
EMA is responsible for the scientific evaluation, primarily of innovative and high-technology medicines developed by pharmaceutical companies for use in the EU.
For more information regarding the operations of the European regulatory system for medicines, you can visit: www.ema.europa.eu
- Lezotre P.L. (2013). International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations. Academic Press.
- Rago, Lembit & Santoso, Budiono. (2008). Drug Regulation: History, Present and Future 1. Drug Benefits and Risks: International Textbook of Clinical Pharmacology, revised 2nd edition.