WORKSHOP ON REGULATORY PROCEDURES FOR TRADITIONAL MEDICINE AND NEW CHEMICAL ENTITIES

The Workshop on Regulatory Procedures for Traditional Medicine and New Chemical Entities was held from 18th to 20th June 2007 at the Parkroyal, Kuala Lumpur and was jointly organized by BiotechCorp, the National Biotechnology Division (BIOTEK) of the Ministry of Science, Technology and Innovation (MOSTI) and the Malaysian Institute of Pharmaceuticals and Nutraceuticals (iPharm). The workshop was officiated by Y. Bhg. Datuk Dr Mohamed Noor Embi, Director of BIOTEK.



The workshop attracted around 150 participants from the pharmaceutical and herbal industry and also from the various universities and research institutes. The three-day workshop marked BiotechCorp’s second collaboration with iPharm. The purpose of the workshop is to complement the R&D efforts carried out in the field of drug development from indigenous plants by providing researchers and manufacturers an understanding of the regulatory requirements in bringing these products into the market place.



The workshop provided a great opportunity for the pharmaceutical industry players especially for the new smaller companies to receive better understanding on the procedural steps they have to take to register their products and also to address any of their concerns should there be any impediments in their efforts during the registration process.



The list of topics and speakers are as follows:-

Control of Drugs and Cosmetics Regulation, 1984
Tuan Haji Ghazali Mansor, Pharmaceutical Services Division, Ministry of Health

Classification of Products
Puan Bariah Binti Abdul Rani, National Pharmaceutical Control Bureau (NPCB)

Registration of Traditional Products
Puan Seetha Ramasamy, National Pharmaceutical Control Bureau (NPCB)

Clinical Trials Permit
En. Zaril Harza Bin Zakaria, National Pharmaceutical Control Bureau (NPCB)

Registration of New Chemical Entities
Puan Azura Abdullah, National Pharmaceutical Control Bureau (NPCB)

Registration of Biotechnology Products
Puan Arpah Abas, National Pharmaceutical Control Bureau (NPCB)

On-Line Registration
Tuan Haji Kamaruddin Ahmad, National Pharmaceutical Control Bureau (NPCB)

Control of Product Quality: Analytical aspect
Puan Faridah Malek, National Pharmaceutical Control Bureau (NPCB

Good Manufacturing Practices
Encik Wan Othman Wan Ismail, National Pharmaceutical Control Bureau (NPCB)

Drug Safety Monitoring

For information on BioMalaysia 2007, please email info@biotechcorp.com.my