Philippines: New regulations of pharmaceuticals

 

Philippines have published two new pharmaceutical regulations:

• Implementing Guidelines of the World Health Organization (WHO) Collaborative Procedure on the Registration of Pharmaceutical Products Approved by Stringent Regulatory Authorities (SRAs);
• Classification of Pharmaceutical Products Intended for Human Use

Regarding the first issue, many countries—including the Philippines—continue to face difficulties in ensuring timely access to new drugs and essential medicines. These challenges largely arise from constraints within national regulatory authorities, such as limited manpower, technical expertise, and infrastructure. Consequently, the evaluation and approval of pharmaceutical products can be delayed, restricting patient access to critical therapies. The increasing volume and complexity of marketing authorization applications, combined with rapidly evolving international standards for safety, efficacy, and quality, further strain regulatory capacity, resulting in prolonged registration timelines and reduced availability of priority medicines in the local market.

To address these concerns, the FDA has implemented several modernization measures in recent years aimed at improving review efficiency and strengthening regulatory functions. These include facilitated registration pathways—such as abridged review, verification review, and the collaborative procedure—introduced through Administrative Order (AO) No. 2020-0045. These pathways form part of the agency’s broader strategy to adopt regulatory reliance and streamline processes while upholding quality and safety standards.

The proposed draft policy also builds upon AO No. 2024-0013, which advances reliance mechanisms as a key component of the FDA’s regulatory framework. By institutionalizing the WHO Collaborative Registration Procedure for products approved by Stringent Regulatory Authorities (SRAs), the FDA will formalize its participation in this globally recognized system, fulfil its commitment to the WHO, and further strengthen alignment with international regulatory practices.

Despite recent progress, a formal, internationally harmonized mechanism is still needed to fully overcome resource limitations and enhance regulatory efficiency. Adoption of the WHO CRP-SRA presents an opportunity to maximize the FDA’s capacity by drawing on assessments already performed by SRAs. Integrating this procedure will not only accelerate the registration of pharmaceutical products but also expand existing reliance mechanisms, ultimately reinforcing the regulatory system and improving public health outcomes.

Regarding the second issue, Republic Act (RA) No. 10918, or the Philippine Pharmacy Act, established the category of pharmacist-only non-prescription pharmaceutical products—OTC medicines that require counselling by a licensed pharmacist prior to dispensing. This category is formally recognized under the law and its Implementing Rules and Regulations. Consistent with its mandate under RA No. 9711, the Department of Health issued Administrative Order (AO) No. 2024-0013, updating pharmaceutical registration requirements and introducing a revised classification system: prescription pharmaceutical products and non-prescription pharmaceutical products. Non-prescription products are further subdivided into pharmacist-only non-prescription pharmaceutical products and general sales non-prescription products (including household remedies). This updated framework promotes safe, rational, and accessible medicine use by ensuring proper classification and balancing public access with patient safety.

The proposed policy seeks to operationalize this new classification framework. Specifically, it aims to establish clear guidelines on the list of active ingredients covered under each category, corresponding labelling requirements, storage and other relevant information, and guidance for all affected stakeholders.