Pharmaceutical Regulation: A Twelve Country Study (A Pharmaceutical Assessment Management and Policy (PAMP) Practicum Report), September 2010
(2010; 62 pages)


This report presents the results and analyses of the regulatory section of a survey on the pharmaceutical sector profiles of 12 countries (Argentina, Armenia, Austria, China, Jordan, Kenya, Maldives, Nigeria, Pakistan, Sri Lanka, Sudan and Suriname). The objective of the 2010 pilot study was to develop model pharmaceutical country profiles. The pilot study precedes a bigger study that will involve all of WHO member states in 2011. Since the World Health Assembly (WHA) passed a resolution in 1975 calling on the WHO to be of greater direct assistance to member states in implementing national programs on pharmaceutical regulation and the formulation of national drug policies, the WHO have undertaken a number of studies to assess the pharmaceutical situation in its member states. These studies included the 1999 World Medicine Situation which was published in 2004, the 2003 levels I and II surveys, the 2007 level I survey, the 2002 ten country study on effective drug regulation, the pharmaceutical regulatory assessments in some member states of the WHO, and the 2010 country profile pilot study of which the regulatory section is the focus of this report... Based on the results of the 2010 pilot study, the following conclusions could be drawn on the pharmaceutical regulatory systems of the study countries:

i) Generally, legal provisions exist that establish the regulatory framework of MRAs in the study countries. Legal provisions on marketing authorization, regulatory inspection, import control, licensing, market control and quality control, medicines advertising and promotion, and controlled substances were common and comprehensive in all of the study countries.

ii) Legal provisions regulating clinical trials and pharmacovigilance were less common in the pilot countries.

iii) Assessments of national regulatory systems within five years prior to the study were undertaken in only seven out of the ten countries.

iv) Out of the twelve countries, eight regulatory agencies were funded by government budgets, seven by fees from user services and eight by funds from other sources which were mainly donors. None of the countries were funded by user fees alone and China was the only country in which the MRA relied solely on the government budget.

v) More MRAs now have their own websites.

vi) Legal requirements that MRAs be transparent in the execution of their mandate were less common. Examples of these provisions include: Legal provisions requiring the declaration of potential conflict of interest for experts involved in the assessment and decision making for registration and the publication of summary product characteristics of registered medicines. Furthermore, the publication of a list of different categories of pharmaceutical facilities and products, the publication of quality testing results, the publication of GMP, GDP and GCP requirements and the publication of the list of complaints and sanctions concerning violation of codes of conducts were rarely done in the countries.

vii) The application fee for the registration of New Chemical Entities and the registration of generic products were the same in three countries, while the former was higher in five other countries. The average ratio of the registration fee for NCE to generic of 3 appears to be too low and does not reflect the promotion of generic products.

viii) Legal provisions on Good Manufacturing Practice were more comprehensive and more common than legal provisions on Good Distribution Practice in the countries.

ix) Though pharmacovigilance activities widely existed in the study countries, legal provisions backing these activities were less common.

x) Compared to health care professionals, consumers less frequently reported ADRs in the study countries.

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