DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)e) Good Manufacturing Practice- GMP from the governmental issuing body declaring manufacturer adherenceto GMP/ ISO or other standards depending on the classification of the productin the country of origin.(Reference: Circular Bil.(3)dlm.BPFK/PPP/01/03Jld.1)1.2 HERBAL TEAa) Raw or crude herbs that contain more than 20% of active ingredients and has atherapeutic or pharmacological effect will be controlled under NPCB;b) Raw or crude herbs that are less than 20% of total active ingredient and arenormally consumed as food will be controlled under the Food Service Division,Ministry of Health;c) Active ingredients in extract forms will have to be registered irrespective of theamount present in the finished product.(Reference: Circular (92)dlm.BPFK/PPP/01/03 Jilid 2)3.3 HOMEOPATHIC PRODUCTSThe following guidance notes are published as First Edition in October 2010 and thelatest revision is on October 2012.This guidance notes serve as an additional reference on the requirements for theregistration of homeopathic products. Other aspects of registration requirements arecovered in the Drug Registration Guidance Document. Applicants for productregistration are also requested to refer to the latest edition on the Guidelines of GoodManufacturing Practices (GMP) for Traditional Medicines.2 nd RevisionAcknowledgementsThe National Pharmaceutical Control Bureau acknowledges its indebtedness to theMalaysia Homeopathic Medical Council and the Traditional & ComplementaryMedicine Division, Ministry of Health who provided comments and advice during thepreparation of these guidelines.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 294