DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)L. CHARACTERISATION• Analytical testing performed to characterise the drug substance with respect toidentity, purity, potency, and stability.• Characterisation of drug substance include physiochemical characterisation,immunological properties and biological activity.• Sufficient sequence information to characterise the product should be obtained.• Post translational modifications should be identified and adequetly characterised,especially when such modifications are likely to differ from those found in naturalcounterpart and may influence biological, pharmacological and immunologicalproperties of the product.M. NONCLINICAL STUDIES• Preclinical testing is a prerequisite to moving a candidate biotechnology productsfrom the laboratory to the clinic and includes all aspects of testing, productcharaterization, proof of concept/ immunogenicity studies and safety testing inanimals conducted prior to clinical testing in humans.• The primary goals of nonclinical studies/preclinical safety evaluation are toidentify an initial safe dose and subsequent dose escalation schemes in humans,potential target organs for toxicity (whether such toxicity is reversible) and safetyparameters for clinical monitoringRef: ICH Topic S6 Preclinical Safety Evaluation of Biotechnology-DerivedPharmaceuticals.N. CLINICAL STUDIES• Clinical studies designed and conducted to meet WHO and international GCPprinciples.• Overall approach to the clinical developement of a medicinal product.• Overview of the clinical findings and provide an evaluation of benefits and risksbased upon the conclusions of the relevant clinical studies.• Interpretation of how the efficacy and safety findings support the proposed doseand target indication.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 162
Drug Registration Guidance Document (<strong>DRGD</strong>)O. POST MARKETING SURVEILLANCE FOR BIOTECHNOLOGY PRODUCT• Provide an outline of the post marketing pharmacovigilance plan.• Periodic safety update report (PSUR) in accordance to ICH Guideline E2C(R1)Clinical Safety Data Management: Periodic Safety Update Reports for MarketedDrugs.• All relevant clinical and nonclinical safety data should cover the period of thereport with exception of updates of regulatory authority or marketingauthorisation holder (MAH) actions taken for safety reasons, as well as data onserious, unlisted adverse drug reactions (ADRs), which should be cumulative.• Risk management planc) REFERENCES FOR VACCINES AND BIOTECHNOLOGY PRODUCTS:i) Vaccines:WHO (http://www.who.int/biologicals/vaccines)i) WHO Technical Report Series: Vaccinesii) Biotechnology Products:WHOi) WHO Technical Report Series 1991 No. 814, Annex 3. Guidelines for assuring thequality of pharmaceutical and biological products prepared by recombinant DNAtechnology. (under revision)ii) WHO Technical Report Series 1991 No 822, Annex 3. Guidelines for assuring thequality of monoclonal antibodies for use in humans.iii) WHO Technical Report Series No 878, Annex 1 and Addendum. Requirements forthe use of animal cells as in vitro substrates for the production of biologicals.iv) WHO Technical Report Series No.786, Annex 3.Requirements for human interferonsprepared from lymphoblastoid cells (Requirements for biological substances N0.42)v) WHO Technical Report Series No.771, Annex 7 Requirements for human interferonsmade by recombinant DNA techniques (Requirement for biological substance No.41)EMAi) CHMP/BWP/157653/07. Production and Quality Control of Monoclonal Antibodiesand Related Substances.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 163
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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