The “Guidance document on Technical Authorization for Manufacture and Regulatory Certifications” will be implemented with effect from the 1 March 2019. This guidance document was presented to the Drug Technical Advisory Committee and discussed with the relevant stakeholders before endorsement from the Bhutan Medicines Board.

The guideline is developed with the aim to guide the potential applicants in fulfilling the technical and regulatory requirements of the Technical Authorization for manufacture of medicinal products in accordance to the Medicines regulation. The guideline also aims for promoting uniformity and transparency in making the regulatory decisions. The requirements in this guidance document have been drawn from international sources such as the World Health Organization (WHO), the Pharmaceutical Inspection Cooperation/Scheme (PIC/S), scientific associations and other regulatory agencies in the region and adopted into our context.

Guidance document on Technical Authorization for Manufacture and Regulatory Certifications