The emerging markets of Asia-Pacific, the Middle East, Africa and Latin America are becoming increasingly important to pharmaceutical companies in their global strategies for the registration of new medicines and making them available to patients worldwide. A major study has been carried out by CMR International that looked at regulatory practices and procedures in these emerging markets from both an agency and industry viewpoint. For the purpose of the study, the countries were divided into three regions: South East Asia and the Western Pacific; The Middle East and Africa; and Latin America.
The main objective was to identify factors that facilitate or impede the efficient registration of new medicines and their timely access to patients. At a regional level, this study revealed many interesting similarities and differences between neighbouring countries and these have been reported separately. When the three regions are compared and a cross-regional view is taken, however, one conclusion becomes evident: Notwithstanding the apparent differences and diversity between the regions, the regulatory aspirations, barriers, problems and priorities, related to the review and availability of new medicines, are essentially similar.
This Briefing is intended as a background document to encourage discussion of the key issues among and between regulatory agencies and companies. These include:
- Ways to improve the efficiency and timeliness of the regulatory review process for new medicines
- Best practices for integrating product certification (the CPP) into the approval process
- The mutual benefits of good communications and transparency in regulatory processes.