Regulatory information and practical manuals
WHO Medicines Regulatory Package
Different models for medicines regulation exist across the world, and in many countries medicines regulatory procedures are still largely ineffective, due to chronic shortages of human and technical resources. Regulatory agencies in developing countries are resource constrained in terms of staffing, standards, systems, and training. As part of the normative role that WHO plays, most of the standards, norms and guidelines have been developed, and the extent of implementation varies from one region to the other. There are a number of factors that explain observed weaknesses of medicines regulation, and these differ from country to country and depend also on the health system. Countries may vary regarding their registration system and not all of them can implement a comprehensive medicine evaluation and registration system.
To support the work and decision making processes of National Medicines Regulatory Authorities (NMRAs), WHO developed a Model Medicines Regulatory Package, which is a collection of existing WHO guidelines and tools, relevant to medicines regulation and presented in a user-friendly form of a standalone CD-ROM.
Model package contains:
- Tools on the establishment and organisation of NMRAs;
- Tools on the definition of requirements and guidance for their implementation;
- Guidance on performance of the regulatory functions of NMRAs;
- Training materials for NMRAs.
Information in the model regulatory package is organized in the following categories:
- Medicines regulation and policies
- Regulatory inspection
- Drug control laboratory
- Good regulatory practices (GRP)
- Non-clinical and clinical trials
- Starting materials
- Manufacturing
- Marketing authorization and product registration
- Importation
- Storage and distribution
- Pharmacovigilance
- Post-marketing surveillance
- Pharmacy practice
- Advertisement and drug promotion
- Rational use
- Disposal of pharmaceuticals
- Risk management
- Information technologies
- Control of narcotics and psychotropic substances
- International cooperation and harmonization
- Pharmacopoeia
- Medical device regulation
- Intellectual property rights
The package is available upon request from the WHO Department of Essential Medicines and Pharmaceutical Policies. Requests for the copy of the Medicines Regulatory Package CD-ROM should be addressed to: mrsmail@who.int