The Promoting the Quality of Medicines (PQM) program helps countries build and sustain effective regulatory systems.
Challenge
Effective medicines regulation is the only way to ensure that medicines are manufactured, imported, stored, distributed, and used according to established quality standards. However, in many low- and middle-income countries, several interrelated factors limit the capacity of regulatory authorities to effectively assure the quality, safety, and efficacy of medicines, and make it harder for them to fulfill their essential functions of protecting citizens and promoting public health.
Approach
PQM works with country regulatory authorities to strengthen and develop effective regulatory systems. The program provides technical assistance to national regulatory authorities and quality control laboratories to build capacity in medicines evaluation, inspection, and quality surveillance. This work empowers regulators with the tools, knowledge, and data they needed to enforce policies, laws, and regulations, and take action to ensure the quality, safety, and efficacy of medicines.
PQM’s technical assistance and guidance helps national regulatory authorities:
- Amend and adopt pharmaceutical quality assurance policies, legislation, regulations, norms, and standards
- Build capacity in essential regulatory functions
- Improve the adoption of international standards
- Maintain quality assurance and quality control
Areas of Technical Support & Training
PQM provides technical assistance and training to strengthen regulatory systems in the following areas:
- Policy, legislation, and regulation
- Guidelines, procedures, and specifications
- Pharmaceutical sector inspection including cGMP inspection
- Dossier review and evaluation
- Medicines registration, marketing authorization, and licensing
- Data standards and regulatory information management
- Quality surveillance program
- Laboratory Quality Management System Strengthening
- Quality assurance
- Quality control
- Good Laboratory and Documentation Practices
- Audits and corrective and preventive action plans
- ISO accreditation and/or WHO prequalification
- Analytical and Consultative Support
- Analytical testing
- Quality control training
- Monograph development
- Quality detection tools, field-based screening technologies