The mission of drug regulatory authorities
Drug regulatory authorities (DRAs) should have a written mission statement which provides a concise, challenging, inspiring vision of what the DRA stands for and what it means to achieve. The core mission for all DRAs is to promote public health by ensuring the quality, safety, and efficacy of Pharmaceuticals. Depending on the country, the mission may also include:
• providing unbiased information and promoting the safe, effective use of drugs.
• ensuring timely availability of drugs (prompt authorization decisions).
• ensuring supervision of the distribution chain.
• stimulating innovation of new medicinal products.
Structure and financing
The structure, staffing, financing and operation of a DRA must be suited to its mission. This may require innovative measures such as establishing a (semi) autonomous agency, implementing user fees for DRA services, and contracting specific functions to nongovernmental bodies.
Independence in decision-making
Independent, autonomous decision-making by DRAs must be backed by appropriate legislation.
Guidelines based on health needs
International guidelines for drug quality, safety, efficacy, and information - including those produced by WHO and ICH - should be based on what is clinically necessary, not simply what is technically possible. Guidelines should be driven primarily by health considerations, not by ever-expanding technology.
Electronic information exchange
In collaboration with WHO, regional and global electronic networks for the exchange of regulatory information similar to the drug information services currently provided in "hard copy" by WHO/DMP should be set up. DRAs in Member States should provide WHO with information on important and significant developments that may be useful to other countries.
Financing of drug regulatory authorities Financing must be adequate and continuously guaranteed to ensure smooth running of the DRA. Financing options include, (a) government financing, (b) user fees or (c) a combination of the two funding sources. Regulatory fees should be based on the real cost of providing DRA services, including drug evaluation, licensing, inspection, quality control testing, etc. It is preferable that a suitable amount of the fees collected for drug regulation services is retained to finance costs of the DRA.
Enforcement of drug control
Legislation and regulation of drugs must be backed up by adequate enforcement mechanisms (i.e. staff, adequate authority), sufficient public/political support, and firm penalties for offences.
Veterinary drugs and DRAs
Because use of veterinary drugs can have direct and indirect effects on human health, Member States should ensure that there is clear and specific responsibility for the registration and quality assurance of veterinary drugs, and for establishing and monitoring maximum residual limits.
Drug information and ethical promotion
DRAs must have the legislative mandate and the necessary mechanisms to ensure accurate drug information and ethical drug promotion. Agreements with industry on advertising rules and the nomination of designated responsible professionals within industry could enhance the effectiveness of regulatory control.
Pharmaceutical products are not commodities and uncontrolled sales through electronic means (Internet) may carry a high risk. WHO should address distance selling and promotion via the Internet, and application of the WHO Ethical Criteria for Medicinal Drug Promotion should be made to such activities.