DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)1.1.3 EXEMPTIONS FOR PRODUCTS USED IN CLINICAL TRIALS ANDMANUFACTURING SAMPLES FOR REGISTRATIONa) Clinical Trial Import License (CTIL)Products which are not registered with the Authority and are intended to beimported for the purpose of clinical trial shall have a Clinical Trial Import License.This is in accordance to the Regulation 12(1)(c), CDCR 1984: “The Director ofPharmaceutical Services may, subject to the provisions of these Regulations,issue the following license subject to such conditions as he may impose, aclinical trial import license in Form 4 in the Schedule, authorizing the licensee toimport any product for purposes of clinical trials, notwithstanding that the productis not a registered product”.b) Clinical Trial Exemption (CTX) & Exemption for Manufacturing Sample forRegistrationi) Products which are not registered with the Authority and are intended to bemanufactured locally for the purpose of clinical trial shall require ClinicalTrial Exemption (CTX) from the Director of Pharmaceutical Services; andii)Any person who wishes to manufacture any product solely for the purposeof producing a sample for registration should apply for an exemption formanufacture of sample. (Applies to locally manufactured products only).This is in accordance to the Regulation 15(5), CDCR 1984: “Any person whowishes to manufacture any product solely for the purpose of producing samplesfor clinical trials, for registration or issuance of notification note under theseRegulation may on application be exempted by the Director of PharmaceuticalServices from the provisions of regulation 7 (1) or regulation 18A”.For more information, please refer Regulation 15, CDCR 1984: Exemptions &Saving; and Guidelines on Clinical Trial.National Pharmaceutical Control BureauFirst Edition, January 201330