DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)5.2.2 CHANGE IN MANUFACTURING SITEChange of Manufacturing Site (COS) refers to change of manufacturing sitefor certain part or all of the manufacturing process of a product, but it does notcover changes related to a new site, where only:a) batch release takes place ORb) to a new packager (secondary packaging or labelling), as these changesare covered under applications for amendments to the particulars of aregistered product (variation).However, a change of manufacturing site for biologics shall require a newproduct application only if the change is extensive that will have an impact onthe quality, safety and efficacy profile of the final product.For details, please refer to Section E: 16.2 Change of Manufacturing Site.5.2.3 CHANGE IN PRODUCT REGISTRATION HOLDERIt refers to a transfer of marketing authorization from the existing productregistration holder (PRH) to another proposed new holder. This applicationallows the same registration number of the registered product to bemaintained.For details, please refer to Section E: 16.3 Change of Product RegistrationHolder.5.2.4 NEW/ ADDITIONAL INDICATIONIt is defined as an indication which was not initially approved for a registeredpharmaceutical product. This shall include new therapeutic indication orindication for a new age group, such as usage in children and shall notinclude changing/ rephrasing of sentences.There are two (2) types of evaluation process available for a new/ additionalindication application, i.e. full evaluation process and verification process.For details, please refer to Section E: 16.4 New/ Additional Indication.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 62