DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)b) BIOTECHNOLOGY PRODUCTSi) DEFINITIONBiotechnological products includes the use of the new genetic tools of recombinantDNA to make new genetically modified organisms or genetic engineering products.Products of recombinant technology are produced by genetic modification in whichDNA coding for the required product is introduced, usually by means of a plasmid orviral vector into a suitable microorganism or cell line, in which DNA is expressed andtranslated into protein. The desired product is then recovered by extraction andpurification.ii) ADDITIONAL REQUIREMENTS FOR REGISTRATION OF BIOTECHNOLOGYPRODUCTS:I. PRODUCTION PROCESSES• The production system shall be well defined and documented.• The effectiveness of the overall purification process for active substance shall bedemonstrated.• Validation of procedures for removing contaminating cellular DNA, viruses andimpurities.J. HOST CELL AND GENE CONSTRUCT• Source of host cells, characterisation, stability, purity and selection.• Information on gene construct, amino acid sequence, vector information andgenetic markers for characterisation of production cells.• Cloning process to form the final gene construct and mapping of sited used inconstructions of final recombinant gene construct.• Method of gene construct amplication and selection of recombinant cell.K. SPECIFICATIONS• Drug substances should include assays for identity, purity, potency,physiochemical and stability.• Identity and quantity of impurities along with analytical data which supportsimpurities profile• Acceptable limits of impurities and should be included in the specifications ifpresent in finished products.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 164
Drug Registration Guidance Document (DRGD)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 | 165
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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