DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)Registration process includes quality control, inspection & licensing as well as postregistrationprocess of medicinal products is illustrated in Figure 2 below:Pre-Submission of RegistrationApplicationSubmission of RegistrationApplication and Screening Process* GMP Inspectionand CertificationData Evaluation** Sample testingMeeting of the Drug Evaluation CommitteeMeeting of the AuthorityRegulatory OutcomeApproval Rejection Appeal*** LicensingPost-Registration Process* Good Manufacturing Practice (GMP) Certification** For natural products only*** Application for Import and/or Wholesale LicenseNational Pharmaceutical Control BureauFirst Edition, January 201326
Drug Registration Guidance Document (DRGD)1.1 REGISTRATION OF PRODUCTSUnder the CDCR 1984, Regulation 2: “Product” means:(a) a drug 1 in a dosage unit or otherwise, for use wholly or mainly by beingadministered to one or more human beings or animals for a medicinal purpose 2 ; or(b) a drug 1 to be used as an ingredient of a preparation for a medicinal purpose 2 .Under Sales of Drug Act 1952, Section 2:1“drug” includes any substance, product or article intended to be used or capable, orpurported or claimed to be capable, of being used on humans or any animal, whetherinternally or externally, for a medicinal purpose.2 “medicinal purpose” means any of the following purposes:(a) alleviating, treating , curing or preventing a disease or a pathological condition orsymptoms of a disease;(b) diagnosing a disease or ascertaining the existence, degree or extent of aphysiological or pathological condition;(c) contraception;(d) inducing anaesthesia;(e) maintaining, modifying, preventing, restoring, or interfering with, the normaloperation of a physiological function;(f) controlling body weight;(g) general maintenance or promotion of health or wellbeing.Note:In this DRGD, the term “medicinal product” refers to the term “product” as stipulatedin the Regulation 2, CDCR 1984.National Pharmaceutical Control BureauFirst Edition, January 201327
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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