EAST ASEAN MARKETS: CHINA AND SOUTH KOREA

EAST ASEAN MARKETS: CHINA AND SOUTH KOREA

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  UNIT : V EASTASIAN MARKETS: CHINA & SOUTH KOREA Drug Registration and Post-Approval Compliance Sarojini Naidu Vanita Pharmacy Maha Vidyalaya (Sponsored by the Exhibition Society) Affiliated to Osmania University, Approved by AICTE & PCI Pothuganti Anjali [1704-25-867-011] M.Pharmacy (RA) 1 Year 2 Semester. Regulatory Aspects of Drugs and Cosmetics.
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  Content  Objectives  China– Regulatory Authority  China – Basic Principles of Registration  China – Pre-Submission Regulatory Planning  China – Clinical Trial & Development Pathway  China – Post-Approval Compliance  South Korea – Regulatory Authority  South Korea – Pre-Submission Regulatory Planning  South Korea – New Drug Registration Requirements  South Korea – Application & Review Process  South Korea – Post-Approval Compliance  Conclusion
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  Objectives Regulatory system fordrug registration in China. Regulatory system for drug registration in South Korea. Post-approval compliance and change management.  Present China and South Korea as two independent regulatory sections.
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  China – RegulatoryAuthority NMPA – National Medical Products Administration: National authority responsible for drug regulation. CDE – Center for Drug Evaluation: Performs technical/scientific evaluation of drug registration applications.  MAH – Marketing Authorization Holder: Responsible for lifecycle management after approval.
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  China – BasicPrinciples of Registration Drug registration covers clinical trials, marketing authorization, registration renewal and supplementary applications/post-approval changes. Key principles: safety, efficacy, controllable quality, scientific evidence, authenticity, accuracy, integrity and traceability of data, clinical value and risk- benefit assessment. China – Drug Categories Traditional Chinese medicines (TCMs). Chemical drugs.  Biological products.
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  China – Pre-SubmissionRegulatory Planning 1. Define product classification and registration route. 2. Identify applicable NMPA/CDE guidelines. 3. Perform a China-specific regulatory gap assessment. 4. Plan quality and manufacturing documentation. 5. Assess acceptability of overseas non-clinical/clinical data. 6. Prepare Chinese labeling and administrative documents. 7. Plan GMP/site inspection readiness. 8. Establish a regulatory communication strategy.
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  China – ClinicalTrial & Development Pathway R&D → Non-clinical studies → Clinical trial application → CDE review → Clinical development → CMC/stability package → Marketing authorization application → CDE technical review → Inspection/testing where applicable → NMPA decision → Drug Approval License → Post-marketing lifecycle management.
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  China – Post-ApprovalCompliance  Run follow-up studies on safety and effectiveness.  Track side effects and report drug reactions.  Monitor real-world use in everyday patients.  Maintain factory standards using GMP guidelines.  Guarantee product quality and batch consistency.  Manage product changes after initial approval.  Submit official paperwork and required reports.  Renew registrations to maintain legal status.
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  South Korea –Regulatory Authority MFDS – Ministry of Food and Drug Safety: Korea’s principal authority for pharmaceutical regulation. Evaluates safety, efficacy and quality through technical review and manufacturing/distribution oversight.  Key functions include marketing authorization, quality standards, GMP oversight, safety surveillance, regulatory guidance and post-marketing supervision.
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  South Korea –Pre-Submission Regulatory Planning Identify product category. Determine applicable MFDS regulations and guidance. Develop CMC/quality package. Plan non-clinical and clinical evidence. Determine bioequivalence requirements for applicable products. Prepare GMP/manufacturing information. Prepare Korean labeling and administrative documents.  Conduct a dossier completeness and consistency check.
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  South Korea –New Drug Registration Requirements Safety and efficacy data. Specifications and test methods. Drug Master File information where applicable. Manufacturer information. Manufacturing and quality data. GMP evaluation information. Drug substance/product data. Container and packaging information. Stability data. Label/package insert.  Imported-product certificates where applicable.
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  South Korea –Application & Review Process  Submission → Administrative/pre-review → Technical review → Safety & efficacy review → Quality/CMC review → GMP/manufacturing inspection where applicable → Regulatory decision → Approval → Post-marketing surveillance.
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  South Korea –Post-Approval Compliance Maintain approved quality standards. Maintain GMP compliance. Monitor adverse events and safety signals. Maintain approved manufacturing conditions. Control manufacturing and quality changes. Keep labels and package inserts current. Submit required regulatory reports/notifications/applications.  Fulfill post-marketing commitments.
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  Conclusion  CHINA: Clinicalevidence must satisfy local ethnic data requirements or multi-regional clinical trial standards.  Good Manufacturing Practice (GMP) compliance is mandatory for manufacturing authorization and facility inspections.  SOUTH KOREA: MFDS-centered scientific review and pharmaceutical oversight, with product-specific requirements for new drugs, data-submission products and generics.  Regulatory Affairs professionals should plan for the complete product lifecycle, from development and registration through post-approval maintenance.
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  References  https://english.nmpa.gov.cn/2022-06/30/c_785628.htm  https://english.nmpa.gov.cn/2022-06/30/c_785633.htm https://www.mfds.go.kr/eng/wpge/m_17/denofile.do  https://www.mfds.go.kr/eng/brd/m_18/view.do?seq=71524&srchFr= &srchTo=&srchWord=pharmaceutical+affairs&srchTp=&itm_seq_1 =0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm= &page=1  https://www.mfds.go.kr/eng/index.do