About

Activities

Scope/Key functions

1

Ensuring safety, quality and efficacy of medicines

· Evaluation, Registration and licensing of medicines and health technology products,

· Issuance of permit to conduct clinical trial, licenses to open pharmacy and recommendation letter to establish manufacturing unit,

· Post marketing surveillance on medicines and health technology products,

· Inspection and monitoring of facilities engaged in manufacture, sales, store and distribution of medicines and health technology products,

· Testing of medicines and HTP before and after registration

2

Promotion of Rational Use of Medicines and health technology products

· Development and revision of national essential medicines list,

· Development and revision of antibiotic prescription protocol,

· Information dissemination to consumer on rational use of medicines

3

Ensuring access to medicines and health care technology products

· Formulate medicine policies to ensure access to medicines

· Price regulation and price transparency

· To issue permit for products in shortage (including orphan drugs)

4

Enforce provisions of drug law for regulatory compliances

· Conduct medicine law awareness activities

· Develop standards and guidelines on medicine registration, pharmacy operation (including hospital pharmacy)

· Train drug inspector to effectively enforce drug law

5

Institutional development including HR

· To review organizational status and develop institutional development plan

· Develop training material for regulatory and analytical staff at all level

· Conduct capacity development activities like building/construction, renovation and training of HR

· Develop capacity strengthening plan of professional in public as well as private sector engaged in medicines and health technology product manufacture, sales, storage and distribution.

· Develop transparent, responsive service delivery system (including online registration, webpage and communication)