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.
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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
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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 Enactment 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).
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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 and other products whose of medicinal products before they are consumption can harm health. placed on the market. The draft law of Burundi mentions the registration function Regulation of the pharmacy profession as part of the Department’s mandate, Regulation of pharmacy professionals – while details were published in 2013 in a pharmacists, pharmaceutical technicians ministerial order3. and pharmacy assistants – is included Provisions for importation of unlicensed in the medicines laws of Kenya and medicines in special circumstances Tanzania (Zanzibar). The laws of Uganda, are found in the laws of Tanzania (both Rwanda, and Tanzania (Mainland) and Mainland and Zanzibar), Kenya and the draft medicines law of Burundi focus Rwanda and in the 2013 ministerial order on regulation of medicinal products, while of Burundi. The law of Uganda is silent on the pharmacy profession is governed by this issue. separate laws1 and is regulated by the professional associations or councils. Compliance with good manufacturing practice (GMP) Licensing of activities and premises Kenya, Tanzania (Mainland and Zanzibar) The laws of Kenya, Uganda, Rwanda and and Uganda have national guidelines Tanzania (Zanzibar) contain provisions for on GMP based at a minimum on WHO licensing of retail and wholesale outlets as GMP standards, and compliance with well as manufacturers of pharmaceuticals. these guidelines is required for medicines The law of Tanzania (Mainland) covers registration in these countries. In Uganda, licensing of manufacturing facilities compliance with GMP guidelines is and wholesale premises engaged in required for licensing of premises under the regulations on Certificate of Suitability 1 Uganda: Pharmacy and Drugs Act of 1970, of Premises, 20144 of the National Drug Chapter 280. Available at: www.ulii.org/ug/ legislation/consolidated-act/280 2 see Footnote 1 United Republic of Tanzania: Pharmacy 3 Gouvernement du Burundi. Ordonnance Act, 2011 (No. 1 of 2011). Available at: Ministérielle Conjointe numéro 630/540/750/11 http:// parliament.go.tz/polis/uploads/bills/ du 02/8/2013 portant mode et conditions acts/1452070670-ActNo-1-2011.pdf. d’homologation des médicaments à usage Rwanda: Law No 45/2012 of 14/01/2013 relating humain et autres intrants pharmaceutiques au to the organization, functioning and competence Burundi. Available at: http://www.minisante.bi/ of the National Pharmacy Council. documents/homologation.pdf. Burundi: Decrèt no 100/150 du 30 septembre 4 Available at: http://www.nda.or.ug/files/ 1980, see also Table 1. downloads/Drug%20Certificate%20of%20
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Act. The guidelines are detailed and in is a core department of the NMRA. The line with WHO’s current GMP standards, quality control laboratories of Kenya, and the NMRA of Uganda is the lead Uganda and Tanzania (Mainland) were the agency on inspections of manufacturing first in the EAC region, and all three are facilities within the framework of EAC- WHO-prequalified. Rwanda has a quality MRH, which signifies the country’s level of control laboratory under the Rwanda strength in this area. The law of Rwanda Standards Board under the Ministry of requires that “pharmaceutical products Trade, Industry and EAC Affairs. Burundi ... are manufactured in compliance has a quality control laboratory under the with relevant principles relating to their National Institute of Public Health (INSP), manufacture” and prohibits manufacture of but according to the national strategic plan pharmaceutical products without a license for laboratory services 2015-20196 it does granted under the law; GMP compliance is not currently serve as a national reference mentioned in a comprehensive guideline laboratory. on registration of medicines compiled by the Technical Working Group on Pharmacovigilance Medicines Evaluation and Registration Although the laws of Kenya, Rwanda of the EAC MRH Programme, which was and Tanzania (Mainland and Zanzibar) approved by the Minister and published mention the follow-up of medicines safety on the website of the Ministry of Health as one of the functions of the regulatory of Rwanda in 20145. In Burundi, GMP authority, they do not contain specific certificates and GMP inspection are provisions for pharmacovigilance activities mentioned in the registration application by the regulatory agencies. Nevertheless, forms, but not in the draft medicines law in Kenya pharmacovigilance is being itself or in the 2013 ministerial order. executed by the Pharmacy and Poisons Board of Kenya in line with specific Quality control laboratories guidelines found on the authority’s In Tanzania (Mainland and Zanzibar) website7, and in Uganda and Tanzania the laboratory is part of the NMRA with pharmacovigilance activities are also appropriate legal provisions. In Kenya carried out by the respective NMRAs. In there is a legal basis for the quality control Tanzania (Zanzibar) medicines safety laboratory, which is however set up as an is monitored by the Zanzibar Food and independent body corporate with its own Drugs Board, while the TFDA is mandated organizational structure and management, to perform this function throughout the where the head of the laboratory does not Mainland. The Pharmacy Task Force report directly to the head of the NMRA. performs pharmacovigilance in Rwanda, In Uganda the legal provisions are not although the medicines law of Rwanda is explicit but implied and the laboratory silent on this issue, as is the draft law of Burundi. Suitability%20of%20premises%20Regulation. pdf 6 Ministère de la santé publique et de la lutte 5 Available at: http://moh.gov.rw/ contre le SIDA. Plan stratégique national de fileadmin/templates/protocols/ laboratoire de biologie medicale du Burundi. APPROVED_MOH_GUIDELINES_ON_ June 2015. Available at: https://www.minisante. SUBMISSION_OF_DOCUMENTATION_ bi/documents/plan_strategique_labo.pdf FOR_REGISTRATION_OF_HUMAN_ 7 Available at: http://pharmacyboardkenya.org/ PHARMACEUTICAL_PRODUCTS.pdf downloads/?file=national_pv_guidelines.pdf
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Control of clinical trials contravene provisions made under the The laws of Tanzania (Mainland and respective laws. The medicines laws of Zanzibar) describe the approval Kenya, Uganda, Tanzania (Mainland and process for clinical trials and include Zanzibar) contain specific provisions for some provisions for informed consent, sanctions including monetary penalties, trial monitoring and reporting. Related revocation of professional and/or product regulations and guidelines are published permits, confiscation of consignments on the TFDA’s website8. Similarly, the law and deportation and imprisonment. The of Kenya mentions the need to conduct maximum fines under the respective clinical trials as a condition for registration medicines laws are five million Tanzania of medicines to establish their safety, Shillings (approx. 2 350 US$), 1 million efficacy or bioequivalence as applicable, Kenya Shillings (approx. 9 800 US$) while a comprehensive guideline on and 1 million Uganda Shillings (approx. clinical trials is available on the PPB’s 300 US$), and the maximum terms of website9. The law of Rwanda contains imprisonment are five years in Uganda, a general statement about the need for two years in Kenya and Tanzania imported and domestically produced (Mainland), and six months in Tanzania pharmaceutical products to undergo (Zanzibar). clinical trials to identify their effectiveness and potential adverse effects related to Discussion their use. However detailed provisions NMRAs are entrusted with ensuring the could not be found in the public domain efficacy, safety and quality of medicines, either for Rwanda or for Burundi. and they are expected to carry out these tasks by applying the best available Provisions to make specific regulations scientific knowledge and skills without The laws of both Tanzania Mainland and bias. A recent achievement that can Zanzibar enable the Minister of Health, support regulatory strengthening on advice of the regulatory authorities, to and convergence in the region is the make regulations pertaining to products publication of the African Union Model and activities regulated under the Law on Medical Products Regulation respective medicines laws. The laws of (5), which covers the key principles of Uganda (Section 61) and Kenya (Section effective medicines regulation. The review 44) provide for making special regulations. of the medicines laws of EAC countries The medicines laws of Rwanda and presented here has identified some Burundi do not contain provisions to make differences and gaps that need to be regulations. addressed.
Sanctions Organizational set-up The medicines laws of Burundi and Good governance including accountability Rwanda do not contain specific provisions and transparency, sufficient competent for sanctions to individuals or entities that human resources to carry out the required 8 Available at: http://www.tfda.or.tz/ tasks, adequate financial resources index/?q=clinical_trials_downloads and freedom from undue influence of 9 Available at: http://pharmacyboardkenya.org/ politics and the interests of individuals, downloads/?file=Guidelines for Conduct of groups and the public are critical for Clinical Trials in Kenya 2016.pdf
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effective medicines regulation. Efficient, Pre-marketing control of products independent and unbiased decision- Medicines registration is at the centre making therefore requires that a sound of the medicines regulatory functions. It organizational structure is in place, involves the pre-marketing assessment giving the authority the power to acquire of data submitted by applicants to and use resources and to appoint and establish the compliance of products with dismiss staff and determine the level of standards of quality, safety and efficacy. their remuneration. The AU Model Law A clear presentation of the technical recommends that authorities should be requirements for registration is important autonomous, although they should remain for effective enforcement, as it gives functionally and financially accountable NMRAs the power to refuse registration to their Ministries. However, of the six or to remove products from registers. The regulatory bodies in EAC partner states laws of Kenya, Tanzania (Mainland and only those of Tanzania (Mainland) and Zanzibar) and Uganda contain detailed Uganda have autonomy in decision-making provisions for registration of medicines on staffing and finances. The other NMRAs with defined standards to be met in terms are Boards or Departments that are of quality, safety and efficacy. In Burundi dependent on resource allocation from the and Rwanda the law contains a general Ministry of Health, an arrangement that can clause, while detailed provisions were affect the efficiency of regulatory activities. subsequently published in an Order of the Minister. These dispositions enable Control of activities the EAC countries in principle to control Through licensing of activities, NMRAs the quality, safety and efficacy of the are able to ensure that medicines are medicines placed on their markets. manufactured, stored, distributed and sold To facilitate convergence of practices in premises complying with regulations and a detailed Medicines Evaluation and that they comply with the specifications Registration Compendium was developed of their marketing authorization until they under the EAC-MRH programme (7). The reach the end users. The NMRAs of compendium is based on the Modules of Kenya, Uganda and Tanzania (Zanzibar) the ICH Common Technical Document are in charge of licensing the full range (CTD) format and can be adapted for of activities and can institute appropriate national use, as has been done in the measures to safeguard the quality of guidelines published in 2014 in Rwanda. pharmaceuticals. In Tanzania (Mainland) Currently, Tanzania through TFDA the responsibilities are divided between serves as a lead agency in Medicines the regulatory authority, which controls Evaluation and Registration in the manufacturing and wholesale (importers’) EAC, and so far work-sharing has been premises, and the Pharmacy Council, successfully demonstrated. Despite which controls wholesalers and retail the effort made, technical capacity in outlets. While this arrangement offers assessment and registration especially of clustering of regulatory activities, it may new chemical entities and biotechnology result in loopholes and inefficiency in derived products still poses a challenge regulation, as the two parties have different towards effective regulation. objectives, standards, processes and Compliance with GMP was found reporting lines (6). to be a requirement for registration of
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medicines in only three of the six laws No quality control laboratory exists in reviewed. In the other countries provisions Burundi. Regional collaboration could offer for GMP compliance were in the form a solution, although cross-border shipment of recommendations and guidance and of samples under controlled conditions may hence not be legally enforceable. and communication of results may pose This increases the risk that medicines are significant logistic and organizational assessed and registered even though they challenges. The absence of quality control are manufactured in facilities that do not laboratories can therefore delay regulatory comply with GMP. In such facilities there actions and impact the patients. is a higher risk of mix-ups and cross- Pharmacovigilance is important to contamination of products, among other detect adverse events observed with threats, with serious potential impact on medicines on the market. Although the health of patients. pharmacovigilance activities are being carried out in EAC countries, the absence Post-market control of products of specific legal provisions in this area Quality control laboratories form an is likely to hinder the effective control important component in effective of safety of registered medicines, as regulation of medicines. Their role is to guidelines published by individual partner offer pre- and post-registration testing of states may not be legally enforceable. product samples in order to confirm that a product conforms with its specifications Control of clinical trials at all times. Functional quality control Effective regulatory control of clinical laboratories are in place in Kenya, trials is another important aspect of Tanzania, Uganda and Rwanda. While medicines regulation. For this purpose, in Tanzania and Uganda both functions laws must contain detailed provisions on are under the same roof, in Kenya the how pharmaceutical companies should laboratory is independent of the NMRA apply for permission to carry out clinical and in Rwanda it is under the Rwanda trials, and how NMRAs in collaboration Standards Board. The latter arrangement with Ethics Committees should perform facilitates independent analysis and ethical and regulatory review, approve reporting of analytical results without clinical trials, inspect clinical trial sites, undue influence by findings from dossier and follow-up periodically on the conduct assessment and inspections. However, it of the trials according to the approved may affect the efficiency of communication protocols. The full range of the above- and delay product registration, since pre- mentioned provisions was not found in all registration testing is a requirement for all the medicines laws reviewed. However, an pharmaceutical products in Kenya10. approval process for clinical trials exists in 10 Pre-registration testing can serve to verify EAC countries, with detailed regulations that the manufacturer’s testing methods for and guidelines available in some of the the product give valid results at the national partner states. Cooperation and capacity- laboratory, but has otherwise been found to building were stepped up when the need have little added benefit as it is rare to find product deficiencies in registration samples for clinical testing was urgent. During submitted by applicants. In recent years it has been recognized that the focus should products circulating in countries comply with the be on targeted, risk-based testing as part specifications of their marketing authorization of post-market surveillance to ensure that on an ongoing basis.
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the Ebola crisis the African Vaccines have to go through the often bureaucratic Regulatory Forum (AVAREF) served as a process of amendment of the main laws common platform for regulators and ethics every time an update is necessary. The committee in reviewing and approving resulting loopholes may encourage acts of clinical trial applications (8). unlawful dealing in medicines, especially as the general statutory laws of EAC Enforcement of legal provisions countries do not have adequate sanctions Enforcement of medicines legislation in place compared to the potential profit to depends to a large extent on the be made by illegal activities. deterrent effect of sanctions. The fines and jail terms specified in the laws of Limitations of this comparison EAC partner states are relatively low The comparison presented in this article compared to the profits often realized by focused on the medicines laws of EAC unlawful dealers of medicines, and are in partner states. It did not systematically no way commensurate to the risks that take into account other laws or the full substandard and counterfeit medicines range of regulations that affect the control pose for the population. By contrast, of medicines. Nevertheless, the findings in a small EU country with 1.4 million identify the main gaps and opportunities inhabitants, Estonia, dealers of medicines for achieving effective regulation through who contravene the provisions of the harmonization and can thus be useful Medicines Act11 are liable to pay fines in improving the legal systems in EAC of up to 32 000 Euro (approximately partner states as part of the ongoing EAC US$ 35 700), and certain offenses are harmonization process. subject to prosecution and punishment The review focused on the main under other laws, for example criminal law. regulatory functions. In addition to providing for these, the AU Model Law Adaptation to change includes some “Miscellaneous provisions” Provisions to make specific regulations on management of conflicts of interest, enable governments to accommodate the the extent of liability of NMRAs for loss or need for new regulatory functions as they damage arising from their decisions, and emerge. The AU Model Law on medical protection of and access to information. products regulation gives the supervisory These aspects were not considered in this authority (i.e. the Ministry in charge of article, although they can have a direct health) the power to make regulations impact on the control of medicines. For and guidelines necessary to pursue example, a review of WHO assessment the objectives of the medicines law, in reports of regulatory systems in African consultation with the regulatory authority. countries (9) found that in many cases Clauses to this effect are included in the medicines regulation is not sufficiently laws of Uganda, Kenya and Tanzania independent from the procurement (Mainland and Zanzibar). The laws of function, and that there is limited Rwanda and Burundi are silent on this public access to up-to-date registers of aspect, and this means that the agencies authorized products, licenced premises and professionals. 11 Republic of Estonia. Agency of Medicines: Medicinal Products Act. https://www.riigiteataja. ee/en/eli/525112013005/consolide
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Conclusion References The medicines laws in EAC partner states 1 International Council for Harmonization cover most of the key regulatory functions, (ICH). ICH guidelines. www.ich.org/ and NMRAs are in place. The laws are at products/guidelines.html different stages of implementation, with 2 EMA. The European regulatory system for some partner states having significantly medicines and the European Medicines Agency. A consistent approach to more regulatory capacity and experience medicines regulation across the European than others. On the other hand, some Union. EMA/437313/2016. London, United of the older laws have not been recently Kingdom: European Medicines Agency, reviewed or amended to keep up with the 2016. pace of pharmaceutical innovation and 3 EAC: Treaty for the Establishment of East technology. Some NMRAs conduct key African Community. August 2007. functions that are not provided for in their 4 Situation analysis study on medicines respective medicines laws. registration harmonisation in Africa. Final Differences were found in the legal report for the East African Community. November 2010. provisions for key regulatory functions as well as in regulatory practices of EAC 5 NEPAD / PATH. Increasing access to high quality, safe health technologies partner states, potentially creating delays across Africa. African Union Model Law on in bringing needed medicines to the Medical Products Regulation. Policy brief. populations and presenting legal loopholes (Undated). that can easily be exploited. The sanctions The full text of the model law is available stipulated in the laws are generally not at http://www.hst.org.za/publications/ african-union-model-law-medical-products- severe enough, nor enforced to a sufficient regulation. extent, to deter unlawful dealing in 6 Mori AT, Kaale EA, Risha. Reforms: a medicines across the EAC region. quest for efficiency or an opportunity The differences and gaps need to be for vested interests’? A case study of addressed in collaboration, since all pharmaceutical policy reforms in Tanzania EAC partner states are faced with similar BMC Public Health. 2013 Jul 13;13:651. health and economic challenges. Future doi: 10.1186/1471-2458-13-651 challenges are likely to be experienced 7 EAC. Compendium of Medicines Evaluation across the region as globalization and Registration for Medicine Regulation Harmonization in the East African and cross-border trade and travel Community. Document No: EAC/TF-MED/ increase. These developments call for MER/FD/COM/N1R0. Version September convergence of regulatory practices in 2014. the region by streamlining the existing 8 The African Vaccine Regulatory Forum legal and regulatory frameworks towards (AVAREF): A platform for collaboration in a common medicines law in the region. a public health emergency. WHO Drug The medicines regulatory harmonization Information 2016; 29(3):127-31. programme in EAC partner states is 9 WHO. Assessment of Medicines Regulatory a good start towards achieving this Systems in Sub-Saharan African Countries. An Overview of Findings from objective. 26 Assessment Reports. Geneva: World Health Organization, 2010. å
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