Pharmaceutical products are highly regulated in most countries and need to comply with strict legislative requirements before being authorized for sale. Individual pharmaceutical regulatory bodies in each country are responsible for ensuring the safety and effectiveness of human and veterinary medicines in their jurisdiction, in compliance with local pharmaceutical legislation. In Australia, the regulatory Agency is the Therapeutic Goods Administration (TGA), in the United States the Food and Drug Administration (FDA) and in Europe the European Medicines Agency (EMA). The EMA is responsible for the simultaneous registration of specific types of products in all European Union Member States, alongside the national competent authorities, which have jurisdiction in each European country.
The regulatory review process consists of the scientific evaluation of all data generated during product development (including drug product manufacture, preclinical testing and clinical trials) which are described in the registration dossier. When data are considered satisfactory (i.e. support the drug’s safety and effectiveness) marketing approval is granted. Expert panels, such as the Australian Drug Evaluation Committee (ADEC) in Australia and the FDA's Advisory Committees in the US, assist regulatory agencies in their evaluation process.
Post-authorisation monitoring is also a responsibility of the regulatory bodies. This includes the on-going safety evaluation of drug products (monitoring of adverse events or side effects caused by the drug) and the evaluation of any changes to the product (formulation, manufacturing process, etc) proposed by the manufacturer. Other tasks performed by regulatory bodies include: carrying out inspections and audits of manufacturing sites and clinical studies to ensure compliance with standards and guidelines and providing sponsors with scientific and procedural guidance. A marketing authorization can be withdrawn when the drug product is found to no longer comply with the conditions of registration or when new data becomes available which does not support the drug’s safety and efficacy. The emergence of new adverse events is generally the primary reason for withdrawal of marketing authorization.
In recent years, a considerable effort has been made to harmonise regulatory requirements (both in terms of scientific content and presentation of data in the registration dossier) across various countries, including the European Union, the USA, Japan, Australia and Canada, among others. The pharmaceutical authorities in various countries also cooperate to exchange information and streamline processing. The Pharmaceutical Inspection Convention Scheme (PIC/S), for example, involves the mutual recognition of Good Manufacturing Practice (GMP) inspections conducted by various agencies across the globe. Harmonisation is primarily aimed at minimising duplication of effort and both the manufacturers’ and the agencies’ resources.
Related posts on the Clinuvel blog
- Compassionate use – navigating the regulatory landscape to ‘do good’ 3/12/2010
- Talking off the label - a review of 'off-label' drug use in three parts: Part 1, Part 2, Part 3 25/10/2009-6/11/2009
- GMP – Good Manufacturing Practice makes perfect 14/10/2009
Read all blog posts tagged with 'FDA'.