埃塞俄比亚制药行业增长以及其法规系统的发展

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Ethiopian Pharmaceutical Industry Growth and Development of its Regulatory Systems

Posted 01 March 2018 | By Amir E. Mohammed

This article examines the growth of the pharmaceutical industry in Ethiopia and presents the processes and pathways for medicinal products to gain market approval. The author emphasizes the need for a strong and well-functioning pharmacy industry given the variety of serious illnesses affecting the population of Ethiopia and its African neighbor states.

Introduction

Ethiopia, located in the Horn of Africa, shares borders with Eritrea to the north and northeast, Djibouti and Somalia to the east, Sudan and South Sudan to the west, and Kenya to the south. With more than 102 million inhabitants, Ethiopia is the most populous landlocked country in the world and the second-most populous nation on the African continent.1 It occupies a total area of 1,100,000 square kilometers (420,000 square miles). Its capital and largest city is Addis Ababa.2 There are growing opportunities for a pharmaceutical industry in Ethiopia with recently introduced government reforms, including a national strategy, a "plan of action" for pharmaceutical manufacturing development, a growth and transformation plan, key participants in the market, and population and disease statistics. These developments have attracted biomedical, pharmaceutical and medical devices companies.3

Ethiopia's Drug Regulatory System

The Ethiopian Food, Medicine and Healthcare Administration and Control Authority (EFMHACA) is mandated by proclamation 661/2009 to ensure the safety, quality and efficacy of medicines that are either imported or locally manufactured for the Ethiopian market. To achieve this, the authority has been working on a variety of regulatory activities, including good manufacturing practice inspection, standardized premarketing dossier evaluation, quality control analysis, port-inspection and post-marketing quality, and safety monitoring.4. However, one of the top priority areas implemented is the medicine market authorization system. In this effort and in addition to dedicated assessors, the authority employs a national drug advisory committee for the assessment and registration of medicines which seek to improve the medicine dossier evaluation system. As the socioeconomic development of the nation transforms, there has been a high flow of investments into healthcare; however, the market authorization system currently available is unable to satisfy or fully accommodate the demand. Contact information for the Ethiopian regulatory agency is listed in Table 1.

Table 1. Contact Information for EFMHACA
Agency	Telephone	Fax	Email	Website
Ethiopian Food, Medicines and Healthcare Administration and Control Authority (EFMHACA)	+251-115-524120/22	+251-115-52411392	regulatory@fmhaca.gov.et	www. fmhaca.gov.et

Medicinal Drug Registration Procedure

Registration of medicines is the focal point of any regulatory framework. The agency's registration section is responsible for reviewing application dossiers submitted for the registration of medicines, related substances and medical devices. In addition, it also reviews all post-registration amendments made to any registered medicines, related substances and medical devices. Those in need of applying for registration of medicines in Ethiopia are guided to download and acquaint themselves with the registration guidelines and the Medicines Application Form (MRF).5

Medicinal Drug Registration Summary

In Ethiopia:

• Medicine application dossiers from pending applications are received, screened for completeness and checked to see that application fees have been included.
• Data on the dossiers is entered into Medicine Registration Information System (MRIS) database and an application number is allocated, and information communicated to the applicant.
• The dossier is scheduled for evaluation by registration section staff. A detailed evaluation report is generated and deficiencies, missing information and gaps needing further work are communicated to applicant and deadline is set for responding to queries outlined.
• Completed dossier reports, pharmaceutical quality laboratory assessment and recommendations are forwarded to the medicine registration and licensing directorate director of FMHACA for approval.
• For molecules new to Ethiopia, the advisory committee recommends whether a product is to be registered. This determination will be forwarded to the registration director.
• Products approved by FMHACA based on the recommendation of the dossier assessor team, the laboratory quality assessment and the clinical review advisory committee receive a registration number and a market authorization certificate. These will be given to the product and the applicant, respectively. The product is then entered into the Medicines Register.
  

To register a product, one must be a registered user of the website and login to the website.6 The registration process, from submission to approval, usually takes three to six months.

Note: the authors' experience with these approval pathways is with a Sandoz Germany, a generic pharmaceutical company, registering medicinal products to be marketed in Ethiopia.

World Health Organization Insight on Ethiopian Pharmaceuticals

According to World Health Organization (WHO), Ethiopia is a model country for local investment in pharmaceuticals, as advocated by three United Nations agencies.7 These agencies are members of the African Union Pharmaceutical Manufacturing Plan for Africa.8 Recently, Ethiopia launched a national strategy and plan of action to develop local pharmaceutical manufacturing capacity and increase access to locally manufactured, quality assured medicines.9 WHO, with support from the European Commission and the Bill and Melinda Gates Foundation, has worked closely with the government of Ethiopia in developing this strategy.

African Pharmaceutical Needs

Africa is home to more than 70 percent of the world's people living with Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS). Up to 90 percent of the world's deaths due to malaria occur in Africa and non-communicable diseases are an increasing problem.10 Due to weak local pharmaceutical manufacturing capacity, the demand for safe, effective and healthy medicines is great. The Ethiopian market for medicines covered by the local manufacturers is less than 15 percent of the total pharmaceutical market, leaving the country largely dependent on imported medicines. It is estimated that in Africa, 79 percent of all pharmaceuticals are imported.11 This fact significantly increases focus on the need for the well-organized and reliable regulation of pharmaceutical products - from dossier submission to awarding certificates for market authorization. This also is an indicator for the need of effective assessment of the dossiers and follow-up on the approved medications to maintain the safety and efficacy of the drug as well as the health of the population.

Political commitment and strong leadership are required to achieve this vision. The Ethiopian government understands its role and is ready to lead. However, the successful transformation of the national pharmaceutical sector and the strengthening of pharmaceutical manufacturing capacity requires the government to improve policy coherence in the pharmaceutical sector. Further support is needed for human capital development, innovation, foreign direct investment, quality assurance systems and strengthening national regulatory authority. A responsive, outcome-oriented, predictable, risk-proportionate and independent medicine regulatory authority is a prerequisite for building a competitive pharmaceutical industry and ensuring safe, quality-assured and efficacious medicine on the market.12 WHO and other international organizations have developed technical standards and offered technical assistance to developing countries. African countries interested in strengthening their pharmaceutical sector should encourage their pharmaceutical manufacturers to apply for WHO prequalification.13. National regulatory authorities also could benefit from such developments.

The determination demonstrated by Ethiopia in transforming its pharmaceutical industries and fostering pharmaceutical products availability, along with the recent proliferation of similar initiative across the continent, sends a clear message that African countries hold long-term visions, aim at integrated and sustainable development and expect national and continental cross-cutting modernization. In this context, international development partners also should find new ways of supporting the efforts of the African continent to eliminate poverty and disease.

Conclusion

When dealing with regulation of pharmaceutical products in Ethiopia, it is important to understand procedures and vital to engage regulatory agencies in drug regulatory program discussions. As the pharmaceutical industry continues to grow in Ethiopia, so does the necessity for understanding the regulatory function. EFMHACA's registration section is responsible for reviewing application dossiers submitted for the registration of medicines, related substances and medical devices. Having clear insight into the process of drug registration enhances the smoothness of the process and permits early approval of market authorizations.

References

• United Nations Department of Economic and Social Affairs (ESA), Population Division. World Population Prospects: the 2017 Revision. ESA website. https://www.un.org/development/desa/en/. Accessed 14 February 2018.
• Ethiopia. The World Fact Book. CIA.
• Analysis of the Ethiopian Pharmaceutical Market. January 2016. https://www.reportlinker.com/p03605445/Analysis-of-the-Ethiopian-Pharmaceutical-Market-.html. Accessed 14 February 2018.
• Food, Medicine and Healthcare Administration and Control Authority of Ethiopia (EFMHACA) website. http://www.mris.fmhaca.gov.et. Accessed 14 February 2018.
• EFMHACA's Guideline for Registration of Medicines of 2014. http://apps.who.int/medicinedocs/documents/s23058en/s23058en.pdf. Accessed 14 February 2018.
• Ibid.
• Sidibe, M., Yong, L. and Chan, M. "Commodities for Better Health in Africa–Time to Invest Locally." Bull World Health Organ. 2014 Jun 1;92(6):387–387A. http://dx.doi.org/10.2471/BLT.14.140566. Accessed 14 February 2018.
• African Union Commission's Pharmaceutical Manufacturing Plan for Africa: Business Plan. Addis Ababa: African Union Commission and United Nations Industrial Development Organization; 2012.
• National Strategy and Plan of Action for Pharmaceutical Manufacturing Development in Ethiopia (2015–2025) [abridged version]. Addis Ababa: Government of Ethiopia; 2015.
• Revitalizing Africa's Pharmaceutical Industry. Abidjan: African Development Bank Group; 2014. Available from: http://allafrica.com/stories/201406041633.html. Accessed 14 February 2018.
• Ibid.
• Riviere, J.E. and Buckley, G.J. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington: National Academies Press; 2012.
• Quality Assurance of Pharmaceuticals, WHO Guidelines, Related Guidance and GXP Training Modules. Geneva: World Health Organization; 2014. http://digicollection.org/whoqapharm/. Accessed 14 February 2018.  
  

About the Author

Amir Mohammed is a regulatory affairs specialist for Sandoz Germany, a pharmaceutical company based in Ethiopia, and a regulatory consultant. Mohammed worked in local pharmaceutical manufacturing companies in Ethiopia and in marketing sector before joining Sandoz and becoming a regulatory consultant. He can be reached at amirregulatoryconsulting@yahoo.com.

Cite as: Mohammed, A. "Ethiopian Pharmaceutical Industry Growth and Development of its Regulatory Systems." Regulatory Focus. February 2018. Regulatory Affairs Professionals Society.

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beiwei5du

Pharmaceutical Regulatory Framework in Ethiopia: A Critical Evaluation of Its Legal Basis and Implementation
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4913194/

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