The majority of African populations use traditional medicine for their health care needs which is often bought in places such as open markets and local stores. Although many traditional medicines are claimed to cure various diseases, scientific evidence of safety, efficacy or quality is lacking and most countries in sub-Saharan Africa have no regulation, safety-monitoring or pharmaco-vigilance centres for the pharmaceuticals or herbal products sold on their markets. As with conventional medicines, this lack of regulatory control will compound the risks to patients. In view of this situation, the WHO Regional Committee for Africa has adopted the Regional Strategy on Traditional Medicine which urges Member States to develop systems for the safety, efficacy and quality of traditional medicines.

In order to support Member States to facilitate the evaluation of traditional medicines for registration purposes, the WHO Regional Office for Africa, organized the first Regional workshop on Regulation of Traditional Medicines in Johannesburg, in April 2003 in collaboration with the Department of Essential Drugs and Medicines Policy in WHO Geneva. The workshop was attended by 18 national drug regulatory authorities and experts from: Benin, Burkina Faso, Congo, Cote d’Ivoire, Ghana, Ethiopia, Kenya, Madagascar, Mali, Mozambique, Nigeria, South Africa, Swaziland, United Republic of Tanzania, Uganda, Zambia and Zimbabwe. The document Guidelines on Registration of Traditional Medicines in the WHO African Region was reviewed and adopted at that workshop.

The Second Regional Workshop on Regulation on Traditional Medicines has been organized in Madrid, Spain, 13-14 February 2004, with the objective of promoting the registration and marketing of safe, effective and good quality traditional medicines within the African Region. The workshop was organized by WHO with support from the Spanish Agency for Medicines and Health Products in Madrid, Spain.

The purpose of the Second Regional Workshop was to expand WHO’s support in building capacity to regulate herbal medicines in countries of the WHO African Region, according to their national situation. Guidelines on Registration of Traditional Medicines in the WHO African Region were presented at the workshop which brought together 15 invited national drug regulatory authorities and experts from Angola, Burkina Faso, Cameroon, Congo, Ghana, Lesotho, Liberia, Madagascar, Namibia, Niger, Nigeria, Sierra Leone, Togo and Zimbabwe. This workshop also provided an opportunity for participants to attend the Eleventh International Conference of Drug Regulatory Authorities (See page 3). Against this framework, the workshop focused on three themes:

• Regulation and registration of traditional medicines,
• Quality control of traditional medicines, and
• Safety monitoring and pharmacovigilance of traditional medicines.

Recommendations

The Workshop identified major challenges and made recommendations for each of the three themes as follows.

Major challenges include:

• Lack of national policies and legal framework on traditional medicine in most countries of Africa.

• Lack of registration of herbal medicines.

• Difficulty in evaluating the safety and efficacy of traditional medicines.

• Lack of minimum regulatory requirements for safety and efficacy of traditional medicines.

• Lack of methodology and tools for evaluation of traditional medicines particularly lack of information on clinical data.

• Lack of understanding by traditional health practitioners on the need for regulation of traditional medicines.

• Lack of protection of medicinal plant and traditional medical knowledge.

Recommendations for Member States

1. Member States should adopt WHO guidelines related to national policy, legal framework, and code of ethics, regulation and registration of herbal medicines and formulate appropriate national policies.

2. Member States should establish/strengthen legal frameworks to back up the national policy on traditional medicine.

3. Member States should set up a communication network between national drug regulatory authorities and associations of traditional health practitioners.

4. Member States should undertake a listing of traditional medicines in circulation within their countries.

5. Member States should adopt and implement a WHO Regional framework on protection of traditional medical knowledge and intellectual property rights of traditional medicine.

6. Member States should develop a national inventory of commonly used medicinal plants.

Recommendations to WHO and partners

WHO and partners should support Member States to:

• formulate national policies on traditional medicine.
• develop strategy to implement the regulation of traditional medicine.
• develop inventories of traditional medicinal products in circulation within the countries.

Quality control of traditional medicines

Major challenges include:

• Lack of expertise in quality control of herbal medicines among national drug regulatory authorities.
• Inadequate laboratories and equipment for quality control of traditional medicines.
• Lack of pharmacopoeia of national medicinal plants for quality control of traditional medicines.

Recommendations for Member States

1. Member States should strengthen human resources capacity to undertake quality control of herbal medicines.

2. Member States should adopt and implement WHO guidelines on Good Agricultural and Collection Practices of Medicinal Plants and Good Manufacturing Practices for Herbal Medicines.

3. Member States should develop national monographs/pharmacopoeia of medicinal plants and share this information. The use of WHO monographs, African Pharmacopoeia and other national monographs for quality control should also be encouraged.

4. Member States should strengthen national quality control laboratories to be able to control the quality of herbal medicines or set up a network with other domestic research institutes which have a capacity to carry out quality control of herbal medicines.

5. If needed, Member States could use Regional quality control laboratories from neighbouring countries through WHO country and Regional Offices for Africa.

6. Member States should strengthen communication amongst national drug regulatory authorities and between them and importing and exporting countries of herbal medicines.

Recommendations to WHO and partners

1. WHO and partners should:

• support countries to strengthen the capacity of countries for quality control.
• support countries to undertake an inventory of medicinal plants commonly used in their communities.
• support countries to develop their national pharmacopoeia or monographs of medicinal plants.

Safety monitoring and pharmacoviglance

Major challenges:

Most countries in the WHO African Region have no safety monitoring or pharmacovigilance system for essential or herbal medicines.

Recommendations for Member States

1. Member States should set up a safety monitoring and pharmacovigilance system and the expand existing system to cover safety monitoring and pharmacovigilance of herbal medicines.

2. Member States should control advertisements of herbal medicines.

3. Member States should develop consumer educational information on the proper use of traditional medicines.

Recommendations to WHO and partners

1. WHO and partners should

• support Member States to develop consumer educational information on the proper use of traditional medicines.

• facilitate communication between Member States of the WHO African Region and WHO Collaborating Centre for Safety Monitoring in Uppsala, Sweden.

• support requests on human resource development in safety monitoring of herbal medicines.

Besides the above-mentioned recommendations, Member States proposed that WHO organize an African Conference of Drug Regulatory Authorities on Herbal Medicines every two years.

Conclusion

The Regional workshop facilitated sharing of information on the minimum regulatory requirements for the assessment of the quality, safety and efficacy of traditional medicines with respect to their registration as laid down in the Guidelines for Registration of Traditional Medicines in the WHO African Region; and

The Workshop also made a review of the regulatory status of traditional medicine including the results of the global survey on regulation of herbal medicines and national policy on TM/CAM at both regional and global levels.

The Workshop also discussed the impact of the WHO guidelines on Good Agricultural and Collection Practices of Medicinal Plants and Safety Monitoring and Pharmacovigilance of Herbal Medicines (see below).