Pakistan Seek for Help to Regulations Harmonisation with Global Best Practices

| By | Pakistan, Regulatory

The Drug Regulatory Authority of Pakistan (DRAP) is recruiting a consultant to help it harmonize its rules and regulations with international best practices. DRAP wants the consultant to work on areas including licensing, registration, inspection, market surveillance and pharmacovigilance.

Harmonization is one of nine items on the scope of work shared by DRAP. Some of the other items on the list also relate to harmonization. For example, DRAP wants the consultant to help it prepare to meet the requirements of the Pharmaceutical Inspection Co-operation Scheme membership and attain the next maturity level in the World Health Organization’s global benchmarking tool.

DRAP also wants the consultant to help it draw up a roadmap for signing a memorandum of understanding with other regulatory authorities. The goal is for DRAP to cooperate with its global peers on areas including compliance with manufacturing rules and regulatory information sharing.

Other related tasks awaiting the consultant include improving DRAP’s inspection, enforcement and compliance activities in line with international standards. DRAP hopes that change will help grow exports of pharmaceuticals. Another point on the scope of work is focused on the development of a framework for how DRAP and the Pakistani drug industry can work to increase exports.

The scope of work also addresses the development of guidance on topics including clinical trials, the creation of a framework to strengthen DRAP’s user fee program and the improvement of a quality management system.

DRAP is accepting proposals from consultants interested in taking on the work until 28 October.

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