Consultancy on Country Regulatory Support (Албания - Тендер #37023440)

BACKGROUND

Strengthening of the National Regulatory Authorities is one of the fundamental strategies for countries to advance Universal Health Coverage. Efficient regulatory systems will ensure that only medical products meeting appropriate standards of efficacy, safety and quality can enter the market.

WHO has been taking an active role in helping Member States to strengthen regulatory systems as part of the overall health systems strengthening, including facilitation of good decision-making processes, development of technical competency, harmonization and convergence of global norms and standards. Despite significant progress being made, many countries are still struggling to implement critical regulatory functions to the minimum level that is required by the World Health Assembly resolution WHA67.20 (2014). Strengthening regulatory systems requires a wide range of knowledge and technical expertise in various regulatory functions. Most countries have limited resources to exert all regulatory functions, therefore strategies and approaches need to be resource-considerate and practical. Recent approaches include the promotion of regulatory cooperation, convergence, and harmonization to address regulatory capacity gaps between countries and introduction of a global benchmarking process to streamline strengthening activities.

The work of this consultancy contributes to country support on the overall implementation of the Western Pacific Regional Action Agenda on Regulatory Strengthening, Convergence and Cooperation for Medicines and the Health Workforce (RC68.R7, 2017).