Minimum Regulatory Functions required for Drug Regulatory Authorities in LMICs
Drug regulatory authorities (DRAs) in low- and middle-income countries (LMICs) must focus on a set of core functions to ensure safe, effective, and high-quality medicines are available to their populations.
Minimum (essential) Regulatory functions
Regulatory authorities in LMICs may face specific challenges such as limited resources, lack of infrastructure, and insufficient technical expertise. Strategies to overcome these barriers could include seeking international cooperation, leveraging technology for drug licensing management systems, and prioritizing high-risk areas for regulation.
- Drug Registration and Market Authorization:
- DRAs must evaluate and approve new drugs before they can be marketed.
- Safety and Efficacy Evaluation: DRAs should assess drug product manufacturing and quality data to ensure it is both safe and effective for use.
- Quality Control: Testing of drug product samples for compliance with the established standards before granting market authorization.
- DRAs must evaluate and approve new drugs before they can be marketed.
- Post-Market Surveillance:
- Continuous monitoring of drugs once they are on the market.
- Adverse Drug Reaction Reporting: Establishing a national adverse drug reaction reporting system for marketed products to collect data on side effects from healthcare professionals and patients.
- Pharmacovigilance: Proactively reviewing data from health facilities to identify and analyze patterns of adverse effects or drug ineffectiveness. Providing infrastructure/resources for management and reporting of adverse events.
- Continuous monitoring of drugs once they are on the market.
- Good Manufacturing Practice (GMP) Inspections:
- Ensuring pharmaceutical manufacturers comply with GMP standards.
- Regular Inspections: Conducting regular, scheduled and surprise inspections of manufacturing plants to assess compliance with current GMP guidelines.
- Certification and Licensing: Issuing GMP certificates to manufacturers and follow-up for renewals based on consistent compliance.
- Ensuring pharmaceutical manufacturers comply with GMP standards.
- Import and Export Control:
- Regulating the import and export of pharmaceutical products.
- Import Quality Verification: Inspecting imported active pharmaceutical ingredients (APIs) and finished drug products’ consignments at ports of entry to verify that they meet national quality standards and are authorized for legal distribution in the market.
- Permit Issuance: Granting import permits to pre-approved suppliers only to ensure the integrity of the supply chain and thus law-full distribution within the country.
- Regulating the import and export of pharmaceutical products.
- Regulation of Clinical Trials:
- Overseeing clinical trials to protect participants and ensure ethical practices.
- Ethical Review Boards: Establishing Institutional Review Boards (IRBs) to evaluate the ethical implications of proposed clinical trials.
- Trial Monitoring: Conducting site visits and audits to ensure adherence to approved protocols and regulatory requirements.
- Overseeing clinical trials to protect participants and ensure ethical practices.
- Licensing of Pharmaceutical Professionals and Facilities:
- Ensuring that individuals and establishments involved in the drug supply chain, including manufacturers and testing laboratories, are qualified and compliant.
- Professional Licensure: Requiring qualified individuals and pharmacists to register, obtain and renew market authorization licenses periodically, ensuring they meet continuing education standards and have knowledge of the regulatory requirements specific for procurement, storage, and distribution of drugs.
- Facility Licensing: Mandating that pharmacies and drug stores obtain operating licenses based on adherence to specific standards.
- Ensuring that individuals and establishments involved in the drug supply chain, including manufacturers and testing laboratories, are qualified and compliant.
- Public Awareness and Education:
- Informing the public and healthcare providers about safe drug use.
- Public Health Campaigns: Crafting effective strategies for public awareness. Disseminating information on the dangers of falsified and counterfeit drugs through media campaigns.
- Provider Training: Offering workshops for healthcare providers on the latest drug safety protocols and reporting mechanisms. Providing resources for proper implementation of these requirements.
- Informing the public and healthcare providers about safe drug use.
Regulatory authorities in LMICs may face specific challenges such as limited resources, lack of infrastructure, and insufficient technical expertise. Strategies to overcome these barriers could include seeking international cooperation, leveraging technology for drug licensing management systems, and prioritizing high-risk areas for regulation.
By concentrating efforts on these minimum regulatory functions, DRAs in LMICs can create a robust framework to ensure the availability and safe use of medicines, ultimately contributing positively to public health outcomes and thus significantly reducing healthcare services expenditure.
Tentative revision: March 2025
Disclaimer: The views and opinions expressed on PharmaRead are those of the authors and do not necessarily reflect the official policy or position of any agency or organization. PharmaRead articles are provided for information only with a focus on global health, pharmacy practice, and healthcare systems in Low- and Middle-income Countries (LMICs). Readers should seek expert opinion for use, implementation or application of this knowledge based on their individual circumstances.