إجراء مقترح من الفلبين: المنتجات الصيدلانية

The draft issuance prescribes the guidelines, procedures, documentary requirements, and regulatory framework for the application, issuance, renewal, and monitoring of Certificates of Good Manufacturing Practice (GMP) Compliance for both local and foreign pharmaceutical manufacturers. The measure includes: Requirements for GMP certification of pharmaceutical manufacturers; Procedures for application and evaluation; Mechanism for evaluation (Desktop and on-site inspection); Grounds for suspension, revocation, or cancellation of GMP certificates; The objective is to strengthen regulatory oversight, ensure product quality, safety, and efficacy, and harmonize GMP compliance requirements with internationally accepted standards.