Emerging markets: Regulatory issues and the impact on patients’ access to medicines
2nd-3rd March 2006, Geneva, Switzerland
Introduction
Convened in Geneva, close to the headquarters of the World Health Organization and other major United Nations institutions, this Workshop brought together senior regulators from government agencies and regulatory experts from industry to discuss the factors that help or hinder patients’ access to new medicines in emerging markets.
Recommendations from the workshop
Defining regulatory models
There is a need for much greater openness in recognising the extent and limits of the assessment undertaken by agencies.
It was recommended that future CMR International studies on regulatory agencies in the Emerging Markets should include a classification of the type(s) of review carried out by the agency.
Three main types of review were identified:
- Type 1: Verification assessment
- Type 2: Abridged assessment
- Type 3: Full assessment
Best use of the Certificate of a Pharmaceutical Product (CPP)
The Workshop concluded that lack of flexibility in CPP requirements and reliance on original paper documentation, in an electronic regulatory environment, can significantly impede efficient and timely registration of new medicines.
It was recommended that WHO should initiate a fundamental revision of CPP guidance to better reflect current regulatory practices.
Targets for review times
Concern was expressed about disparities in review times, particularly where prior approval in a major market is a prerequisite. All agencies should be encouraged to set realistic targets for review of new active substances, supported by benchmarking of review processes.
Scientific assessments
The importance of sharing limited scientific resources and avoiding duplication was emphasised throughout the Workshop.
Development of regional consortia was recommended to share expertise and workload, while ensuring regional factors such as stability requirements and medical practice are addressed.
It was recommended that agencies in the Emerging Markets enter formal confidentiality agreements with reference agencies for the exchange of scientific evaluation reports.
Transparency and partnership
Substantial benefits were identified in establishing transparent partnerships between agencies and companies to facilitate timely patient access.
It was recognised, however, that transparency requires resources and expectations must be set at realistic levels.
Guidelines
There was concern that regulatory guidelines are increasingly applied as binding directives. It was recommended that good regulatory practice should ensure guidelines are applied flexibly, allowing justified deviations.
Analysis of samples
Pre-launch testing of new active substances was not considered an effective use of laboratory resources.
Agencies should instead focus on having access to facilities for post-marketing testing to detect counterfeit or substandard products.