Objective: Access to medicines has long been and remains a challenge in African countries. The impact of medicines registration policies in these countries poses a challen'/> Impact of regulatory requirements on medicine registration in African countries – perceptions and experiences of pharmaceutical companies in South Africa
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Impact of regulatory requirements on medicine registration in African countries – perceptions and experiences of pharmaceutical companies in South Africa

机译：法规要求对非洲国家药品注册的影响–南非制药公司的看法和经验

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id="__p1" class="p p-first">Objective: Access to medicines has long been and remains a challenge in African countries. The impact of medicines registration policies in these countries poses a challenge for pharmaceutical companies wanting to register medicines in these countries. The recent AMRHI (African Medicines Registration Harmonisation Initiative) has increased the focus on the need for harmonisation. Medicines registration regulations differ across African countries. Anecdotal evidence, based on the experience of pharmaceutical companies on progress towards harmonisation is somewhat different, i.e. that country specific requirements were a barrier to the registration of medicines. The objective of this study was therefore to determine the nature and extent of regulatory hurdles experienced by pharmaceutical companies who wish to register and supply medicines to African countries. id="__p2">Methods: This cross-sectional descriptive pilot study was conducted across pharmaceutical companies, both local and multinational. These companies were based in South Africa and were also members of Pharmaceutical Industry Association of South Africa (PIASA). The pharmaceutical companies supply both the private and public sectors. An online survey was developed using Survey Monkey. Survey questions focused on the following strands: nature and level of current supply of medicines to African countries by companies, general regulatory requirements, region specific questions and country specific questions across four regional economic communities in Africa, namely; Southern African Development Community (SADC), East African Community (EAC), Economic Community of the West African States (ECOWAS) and Economic Community of Central African States (ECCAS). id="__p3">Results: A total of 33 responses were received to the questionnaire of which 26 respondents were from the PIASA Regulatory working group and 7 were from the PIASA Export working group.It was noted that since most of the regulatory authorities in Africa are resource-constrained, harmonisation of medicine registration policies will contribute positively to ensuring the safety, quality and efficacy of medicines. The experience of pharmaceutical companies indicated that country specific regulatory requirements are a barrier to registering and supplying medicines to African countries. In particular, GMP inspections, GMP inspection fees and country specific labeling were cited as key problems. id="__p4" class="p p-last">Conclusion: Pharmaceutical companies operating in African markets are experiencing difficulties in complying with the technical requirements of individual African countries. Further research is required to provide a balanced perspective on the country specific regulatory requirements vs. the African Regulatory Harmonisation Initiative (AMRHI).
机译：id =“ __ p1” class =“ p p-first”>目标：获取药物长期以来一直是非洲国家的一项挑战。这些国家的药品注册政策的影响对希望在这些国家注册药品的制药公司构成了挑战。最近的AMRHI（非洲药品注册协调倡议）已将重点更多地放在了协调需求上。非洲国家/地区的药品注册规定不同。根据制药公司在协调方面取得的经验，轶事证据有所不同，即国家特定要求是药品注册的障碍。因此，本研究的目的是确定希望向非洲国家注册和供应药品的制药公司所遇到的监管障碍的性质和程度。 id =“ __ p2”>方法：进行了该横断面描述性试验研究本地和跨国制药公司。这些公司位于南非，并且还是南非制药工业协会（PIASA）的成员。制药公司为私营和公共部门提供服务。使用Survey Monkey开发了一个在线调查。调查问题集中在以下几个方面：公司目前向非洲国家提供药品的性质和水平，一般监管要求，非洲四个区域经济共同体的区域特定问题和国家特定问题，即;南部非洲发展共同体（SADC），东非共同体（EAC），西非国家经济共同体（ECOWAS）和中非国家经济共同体（ECCAS）。 id =“ __ p3”>结果：共收到33份问卷调查表，其中26位受访者来自PIASA监管工作组，而7位来自PIASA出口工作组。非洲当局资源有限，统一药品注册政策将对确保药品的安全性，质量和功效做出积极贡献。制药公司的经验表明，特定国家的法规要求是向非洲国家注册和供应药品的障碍。特别是，GMP检验，GMP检验费用和特定国家/地区的标签被认为是关键问题。 id =“ __ p4” class =“ p p-last”>结论：在非洲市场开展业务的制药公司在遵守该法规方面遇到困难。非洲各个国家的技术要求。需要进一步的研究，以提供针对特定国家法规要求与非洲法规协调倡议（AMRHI）的平衡观点。

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