WHO Drug Information Vol. 30, No. 4, 2016 Medicines regulation Comparison of medicines legislation in the East African Community Efficient and aligned regulatory systems are crucial in ensuring access to medical products of assured quality. However, marketing authorizations of needed products are often delayed as researchers and manufacturers must navigate multiple regulatory requirements to register their products across countries. In the East African Community (EAC), efforts are under way for harmonization of technical requirements for medicines regulation. This article presents a comparison of legal and regulatory frameworks for the regulation of medicines in EAC partner states. The findings show some commonalities but also differences and gaps, underlining the need for convergence towards a common medicines regulatory framework in line with international standards. Background a population of 161.3 million people in 2015 it is home to approximately 14% of East African Community the population of the African continent. The East African Community (EAC) was Life expectancies are below the global established in 1999 among the Republics average, and all EAC partner states except of Kenya, Uganda, Rwanda, Burundi and Kenya are low-income countries according the United Republic of Tanzania. With to the World Bank classification(Table 1). Table 1: Demographic characteristics of EAC partner states Partner Land size, Population, Gross domestic Gross national income Life expectancy state km3 million product (GDP), (GNI) per capita*, at birth**, years World Bank million US$ US$ World Bank data data, 2015 World Bank data 2015 (World Bank data 2015) (WHO data, 2015) Kenya 569 140 46.1 63 398 1 340 63.4 Tanzania 855 800 53.5 44 895 910 61.8 Rwanda 24 670 11.6 8 096 700 66.1 Uganda 200 520 39.0 26 369 670 62.3 Burundi 25 680 11.2 3 085 260 59.6 * The World Bank defines low-income economies as those with a GNI per capita of up to US$ 1 025. Lower middle-income economies are those with a GNI per capita of US$ 1 026-4 035. ** Global average 2015: 71.4 years. This article was authored by Mr. Hiiti B Sillo, Tanzania Food and Drugs Authority (TFDA), with input from Mr Sunday Kisoma, TFDA, and Mrs Monika Zweygarth. We thank Professor Eliangiringa Kaale and Professor Veronica Mugoyela from Muhimbili University of Health and Allied Sciences, Tanzania, and Dr Lembit Rägo from the Council for International Organizations of Medical Sciences (CIOMS), Switzerland, for helpful comments on the manuscript. 567 Medicines regulation WHO Drug Information Vol. 30, No. 4, 2016 Medicines regulatory harmonization authorizations are still available for Harmonization initiatives for regulation medicinal products to be marketed in one of medicines started in 1990 when the EU member state only. medicines regulators and the research- Other regional harmonization initiatives based industry of Europe, Japan and are under way in the Association of the United States of America established the Southeast Asian Nations (ASEAN), the International Conference on Harmonization Gulf Cooperation Council (GCC), the Pan of Technical Requirements for Registration American Network for Drug Regulatory of Pharmaceuticals for Human Use (ICH, Harmonization (PANDRH) and the now known as the International Council on Southern African Development Community Harmonisation of Technical Requirements (SADC). for Registration of Pharmaceuticals for Human Use). The objectives of ICH are to EAC medicines regulation harmonization improve the efficiency of drug development Chapter 21, Article 118 of the EAC and registration processes. To date, ICH Treaty (3) provides for co-operation has published guidelines in all areas of on health and specifically asks partner medicines regulation including 12 quality states to harmonize drug registration guidelines, 11 safety guidelines, 18 procedures so as to achieve good control efficacy guidelines and 8 multidisciplinary of pharmaceutical standards without guidelines (1). impeding or obstructing the movement One example of a functioning and of pharmaceutical products, and hence successful regional harmonization facilitate access to pharmaceutical initiative is that implemented by the products within the Community. This is European Union (EU), which offers several expected to increase access to medicinal registration pathways (2). Under the EU products needed to treat health conditions centralized procedure, pharmaceutical that are prevalent in the region. companies submit a single marketing The beginnings of harmonization of authorization application to the EMA. The medicines regulation in the EAC region relevant Committee carries out a scientific go back to 2001, when the technical assessment of the application and gives a requirements for registration of veterinary recommendation on whether or not to grant drugs were approved by the EAC a marketing authorization. Once granted by national medicines regulatory authorities the European Commission, the centralized (NMRAs) as exemplified by the Tanzanian marketing authorization is valid in all EU guidelines. This was followed by a member states. Under the decentralized situation analysis of partner states (4), procedure, applications are submitted and which highlighted some differences in subsequently approved simultaneously regulatory capacity and scope of activities in several member states, one of which as well a lack of institutional mechanisms is designated as the “reference member to share information for example on drug state”. Under the mutual recognition registration or product recalls. procedure, which is applicable to the The EAC Medicines Regulation majority of conventional medicinal Harmonization (MRH) Programme products, already existing national was launched in March 2012. It was marketing authorizations are recognized by the first programme to receive funding one or more EU member states. National under the African Medicines Regulatory 568 WHO Drug Information Vol. 30, No. 4, 2016 Medicines regulation Harmonization (AMRH) initiative through EAC medicines regulatory systems a trust fund established by an agreement between the Bill & Melinda Gates Medicines laws Foundation and the World Bank. The An overview of the medicines regulatory ultimate goal of the EAC MRH programme framework in EAC partner states is shown is to establish a harmonized regulatory in Table 2. Some specific aspects are system in the region that enables approval compared below. of medicines through various regulatory pathways, similar to the regulation model Scope of regulation implemented by the EU Member States. The national medicines regulatory authority (NMRA) of Uganda regulates medicines only, and this includes oversight Table 2: Legal framework for medicines regulation in EAC partner states Partner Medicines law Year of Amend- Regulatory authority Organizational set-up state Enact ment ments Burundi* Décret n° 100/150 du 1980 None Department of Department under 30 septembre 1980 Pharmacy, Medicines the Ministry of Public portant Organisation and Laboratory Health and the Fight de l’exercice de la (DPML) against HIV and AIDS, Pharmacie au Burundi Head: Director Kenya The Pharmacy and 1957 2009 Pharmacy and Statutory body under Poisons Act, Chapter Poisons Board (PPB) the Department of 244 www. Ministry of Health; pharmacyboardkenya. Head: Registrar and org Chief Pharmacist Rwanda Law No. 47/2012 of 2013 None Pharmaceutical Unit of the 14/01/2013 relating Services (Pharmacy Department of to the Regulation and Taskforce) Clinical Services Inspection of Food in the Ministry of and Pharmaceutical Health; Head: Head Products of Pharmaceutical Services Tanzania Tanzania Food, Drugs 2003 2004, Tanzania Food and Government (Mainland) and Cosmetics Act, 2014 Drugs Authority Executive Agency, Cap 219 (TFDA) Head: Director- www.tfda.or.tz General Tanzania The Zanzibar Food, 2006 None Zanzibar Food and Statutory Board under (Zanzibar) Drugs and Cosmetics Drugs Board (ZFDB) the Ministry of Health; Act www.zfdb.go.tz Head: Registrar Uganda The National Drug 1993 None National Drug Semi–autonomous Policy and Authority Authority (NDA) www. organization under Act nda.or.ug the Ministry of Health; Head: Executive Director/Registrar * In Burundi a law relating to regulation of medicines was at the draft stage at the time of writing. This text was obtained from the national medicines regulatory officer and was reviewed for this comparison. No major changes were anticipated until its entry into force. In addition, provisions for medicines registration were published in 2013 in a ministerial order (see Footnote 3 on Page 570 for details). 569 Medicines regulation WHO Drug Information Vol. 30, No. 4, 2016 of the national drug policy and essential importation and exportation, whereas the medicines list. In Kenya the NMRA also regulation of wholesalers and retail outlets regulates poisons. The NMRAs of Tanzania is governed by the Pharmacy Act, 20112 (Mainland and Zanzibar) regulate food, with the controls being implemented by the medical devices, cosmetics and herbal Pharmacy Council. The draft medicines drugs in addition to pharmaceuticals. The law of Burundi does not include provisions law of Rwanda relates to the regulation for licensing of activities. and inspection of food and pharmaceutical products; however no food regulation Provisions for registration of medicines is actually carried out. The draft law Five of the six medicines laws reviewed of Burundi mandates the NMRA to include detailed provisions for registration regulate drugs