1. WHO should develop guidelines to define good regulatory practice and develop appropriate indicators to measure performance. These guidelines should be made available over the WHO website to enable countries to formulate their own standard operating procedures (SOPS).
2. In order to implement good regulatory practice:
• The mission and objectives of drug regulation should be stated clearly so that the attainment of perceived objectives can be assessed adequately.
• Regulatory procedures and outcomes should be transparent to all the stakeholders, including those affected by such regulation, professional bodies, and the public.
• Drug evaluation reports including the rationale used to reach decisions concerning regulatory action should be accessible to the public, as applicable within national legislation.
• The deadline required for the assessment of drug applications should be reasonable, without compromising the safety, efficacy and quality of the product.
• Special considerations should be made to expedite the review of orphan drugs and drugs of special medical or public health value.
• Regulatory authorities should be accountable to the government, those regulated and the public.
• Personnel engaged in drug regulation should be appropriately trained, qualified, competent and of high integrity. Merit-based selection criteria of a high standard should be implemented. Human resource development programmes should be in place to improve the knowledge and skills of staff.
• In the event of dissatisfaction with regulatory decisions, legislative procedures and mechanisms should be in place to allow pharmaceutical companies, consumer groups and the public to lodge official complaints and appeals.
• Access to the latest scientific and technological information should be provided to drug regulatory authorities in order to facilitate their work.
• Regulatory authorities should acknowledge the rights of citizens to receive accurate and relevant information on drugs that are marketed in the country.
• Regulatory authorities should establish mechanisms to ensure the quality of the procedures they operate to.