Registration and Renewal of Pharmacopeia: Ensuring Quality, Effectiveness, and Safety

The Food and Drug Administration (FDA) has issued a comprehensive notification outlining the requirements for registering and renewing pharmacopeia. This notification emphasizes the need for rigorous standards and the submission of supporting documentation that certifies the safety, quality, effectiveness, and appropriate usage of human and animal drugs.

Certification Requirements and Document Submission

Applicants seeking pharmacopeia registration must adhere to stringent certification requirements. For human drugs, this entails providing a Summary of Product Characteristics (SmPC) certified by the World Health Organization (WHO) Prequalification Program, overseen by respected Stringent Regulatory Authorities (SRAs) such as the European Commission, EMA, FDA, JPharm, Swissmedic, Health Canada, and other regulatory bodies.

Similarly, applicants for animal drugs must submit documentation certifying the safety and efficacy of their products. This includes the SmPC or product information from certified foreign organizations such as the European Medicines Agency (EMA) through its Veterinary Mutual Recognition Index (VMRI), the Heads of Medicines Agencies (HMA), the UK’s Veterinary Medicines Directorate (VMD), the U.S. Food and Drug Administration, the U.S. Department of Agriculture (USDA), as well as regulatory bodies overseeing animal drugs in Canada, Australia, New Zealand, Japan, various European Union member states (Ireland, Austria, Germany, Spain, France, Italy, Belgium, Netherlands, Hungary, Czech Republic, and Bulgaria), and South American countries like Brazil and Mexico.

Detailed Information and Certification

To ensure transparency and accountability, the notification specifies the essential information that must be included in the certifications. This includes the name of the drug, its strength unit, form, indications for usage, size, usage instructions, applicable species, and drug withdrawal periods.

Safeguarding Public Health and Responsible Use of Pharmaceuticals

The Notification plays a vital role in establishing clear and stringent guidelines for the submission of documentation and evidence regarding the quality, effectiveness, and safety of drugs. By adhering to these guidelines, applicants for both human and animal drugs are required to meet rigorous standards and certification requirements. This ensures that public health is safeguarded, and pharmaceutical products are used responsibly.

Facilitating a Robust and Transparent Evaluation Process

By specifying the necessity of certifications and detailing the required information, such as drug names, strength units, indications, and withdrawal periods, this Notification facilitates a robust and transparent evaluation process for extending pharmacopeia registration. Furthermore, it promotes international harmonization efforts by recognizing certifications from reputable organizations and regulatory authorities worldwide.

Upholding the Highest Standards in Pharmaceutical Quality

Ultimately, this Notification serves as a critical tool within the regulatory framework, fostering confidence in the safety and efficacy of pharmaceutical products for both human and animal use. It reflects the unwavering commitment of regulatory bodies to uphold the highest standards in pharmaceutical quality, ensuring that consumers can trust the drugs they rely on for their well-being.

Author: Panisa Suwanmatajarn, Managing Partner.

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• Registration and Renewal of Pharmacopeia: Ensuring Quality, Effectiveness, and Safety