DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)indication, that ingredient must contribute to that indication. The evidencemay be scientific and or traditional.b) Overages of active ingredientOverages may be used during manufacture. An overage is where the amountof an ingredient added during manufacturing that is greater than thenominated on the product label. Details of the overage used must beavailablec) Listed active ingredients can be checked through http://www.bpfk.gov.my ofproduct search. Ingredients not listed will require safety and/or efficacy dataevaluation prior to addition to this list.d) For new active ingredients or new combination products, the followinginformation shall be required:‣ Product containing new single ingredient:i) Extract form- Information on the taxonomy of the ingredient;- Techniques and methods in preparing/ processing the extract andsubsequently the product;- Information on the use and safety of the ingredient and the productQuality standard.ii) Powder/ Granules- Information on the taxonomy of the ingredient;- Techniques and methods in preparing/ processing the extract andsubsequently the product;- Information on the use and safety of the ingredient and the product.‣ Product containing multiple ingredients (contains ingredients which areknown to be used traditionally):- The source of the product formulation;e.g. Chinese Pharmacopoeia- Proof or evidence of the use, traditionally.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 244
Drug Registration Guidance Document (DRGD)‣ Product containing multiple ingredients (contains ingredients which are notknown to be used traditionally):- Information on the use and safety of every new ingredient;- Safety data on the new formulation;- Regulatory status in other countries.2.1.2 PREMIXEffective from 1 December 2007, premixed ingredient(s) shall not be used ina traditional product formulation, as directed in circular Bil (71) dlmBPFK/02/5/1.3, 1 Jun 20072.1.3 PROHIBITED/ BANNED INGREDIENTSThe following lists are prohibited/ banned ingredients which are not allowed inthe formulation of natural products registered by the Authority:a) Botanicals (and botanical ingredients) containing scheduled poisons aslisted under the Poisons Act 1952;b) Botanicals (& botanical ingredients) which are banned due to reportedadverse event;c) Ingredients (botanicals and substance derived from animals) which arebanned due to safety reasons.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 245
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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