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Filipiny: Nowe wytyczne dotyczące wycofywania produktów zdrowotnych Filipiny opublikowały Wytyczne dotyczące wycofywania produktów zdrowotnych regulowane przez Agencję ds. Żywności i Leków. Krajobraz regulacyjny dotyczący produktów zdrowotnych na Filipinach uległ znaczącym zmianom, dlatego też pierwotnie wydane Wytyczne dotyczące wycofywania produktów z rynku wymagają przeglądu. Ogłoszono okólnik mający na celu utworzenie...

Korea: Amendments to the Regulations on Safety of Pharmaceuticals   South Korea published new amendments to its Regulations on Safety of Pharmaceuticals, proposed by the Ministry of Food and Drug Safety (MFDS) in the Notification No. 2023-550 of 29 November 2023. The amendments include: Improvement of regulations related to submission for Marketing Authorization (revision of...

Philippines: Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price (MRP)   Philippines has published Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price (MRP). The proposed Guidelines aim to provide streamlined and rational application  process  for  the  change  of  labeling  materials  under  MRP  including  drug molecules or drug formula that...

EU: Derogations for medicinal products from the United Kingdom   The EU Commission has published a Proposal for a Directive of the European Parliament and of the Council amending Directives 2001/20/EC and 2001/83/EC as regards derogations from certain obligations concerning certain medicinal products for human use made available in the United Kingdom in respect of...

Philippines: Revision of the Guidelines on Good Manufacturing Practice (GMP) Clearance for Foreign Drug Manufacturers   Philippines has published a new draft Administrative Order concerning Revised Guidelines on Good Manufacturing Practice (GMP) Clearance for Foreign Drug Manufacturers. The purpose of the revision is to update the current guidelines on the Foreign GMP Clearance requirements and...

Singapore: Health Products (Therapeutic Products) Regulations   Singapore has published Health Products (Therapeutic Products) Regulations – Presentation of Therapeutic Products regulations 19 and 20 and Guidance on Therapeutic Product Registration in Singapore: Applicable labelling requirements in Appendix 7 on Points to consider for Singapore Labelling. Therapeutic products in Singapore are subject to labelling requirements that...

Russia: Draft guideline for the pharmaceutical development of medicinal products for use in paediatric practice   Russia has published a Draft guideline for the pharmaceutical development of medicinal products for use in paediatric practice. The draft guideline on the pharmaceutical development of medicines for use in paediatric practice provides for the need to establish unified...

Panama: New Decree implementing Law on medicines and other human health products   Panama has published a draft Draft Executive Decree implementing Law No. 1 of 10 January 2001 on medicines and other human health products. The notified Executive Decree sets out the implementing regulations for Law No. 1 of 10 January 2001, which regulates...