DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)APPENDIX 3:GUIDELINES ON REGISTRATION OF BIOLOGICSIMPORTANT NOTES:1. This document shall be read in conjunction with the relevant sections of the mainguidance document: Drug Registration Guidance Document (DRGD), which is inaccordance to the legal requirements of the Sale of Drugs Act 1952 and theControl of Drugs and Cosmetics Regulations 1984.2. The National Pharmaceutical Control Bureau‟s (NPCB) requirements for registration ofbiologics/ biopharmaceuticals products are aligned with the scientific guidelines andrecommendations for quality, clinical efficacy and safety and non-clinical of the WorldHealth Organization (WHO), European Medicines Agency (EMA) and InternationalConference of Harmonization (ICH).3. Where appropriate, the relevant WHO, EMA and ICH guidelines on biologics/biopharmaceuticals shall be consulted.WHO (http://www.who.int/boodproducts/en/index.html)EMA (http://www.ema.europa.eu)ICH (http://www.ich.org)4. Every biologic is regulated as a new product and also considered „high risk‟, itmust comply to Good Manufacturing Practice strictly. Adoption of GMP as an essentialtool of Quality Assurance System.5. The requirements for registration of biologics/ biopharmaceuticals shall be inaccordance to the ASEAN Common Technical Dossier (ACTD) format and inadherence to the general regulatory requirement as described in sections of the mainDRGD. It covers:Administrative informationProduct quality dataProduct safety dataClinical data, demonstrating clinical efficacy and capacity to meet therapeuticclaims, through clinical studies.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 154
Drug Registration Guidance Document (DRGD)6. Animal derived materials/ products are commonly used in the manufacture of biologics/biopharmaceuticals. Please provide detail information regarding the rationale for use ofsuch material, the source etc., as per Checklist A and Checklist B; and also provide aconfirmation on the presence/ absence of the animal materials in the final product.7. Since biosimilars are follow-on products of the original biopharmaceutical products(well-characterised recombinant proteins), this document also is applicable tobiosimilars. Additionally, a separate Guideline for Registration of Biosimilars isavailable.8. This document is intended to provide guidance for the registration of biologics.However, the document will serve as a living document that will be updated/ revisedfurther in the line with the progress in scientific knowledge and experience.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 155
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PART III: NON-CLINICAL DATADrug Reg
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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