Industrial perceptions of medicines regulatory harmonization in the East African Community.

ABSTRACT:

Background

Medicines regulatory harmonization has been recommended as one way to improve access to quality-assured medicines in low- and middle-income countries. The rationale is that by lowering barriers to entry more manufacturers will be enticed to enter the market, while the capacity at the national medicines regulatory authorities is strengthened. The African Medicines Regulatory Harmonization Initiative, agreed in 2009, is developing regional platforms with harmonized regulatory procedures for the registration of medicines. The first region to implement medicines regulatory harmonization was the East African Community (EAC). The harmonization was based on the existing EAC Free Trade Agreement, which officially launched the free movement of goods and services in 2010.

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SUBMITTER: Dansie LS 

PROVIDER: S-EPMC6583972 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature