G/TBT/N/MYS/66  
 
23 February 2016  
(16-1094)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: MALAYSIA 
If applicable, name of local government involved (Article 3.2 and 7.2):  
2. Agency responsible: 
National Pharmaceutical Control Bureau 
Ministry of Health 
Lot 36, Jalan Universiti 46200 Petaling Jaya 
Selangor 
Phone: (+603)78835400 Fax: (+603)79551030 Email: karlsal@bpfk.gov.my   
Website: http://portal.bpfk.gov.my/   
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above : 
3. Notified under Article 2.9.2 [X], 2.10 .1 [ ], 5.6.2 [ ], 5.7.1 [ ], other: 
4. Products covered (HS or CCCN where applic able, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable): Generic products to be 
registered for marketing authorisation in Malaysia. Pharmaceutics (ICS: 11.120) 
5. Title, number of pages and language(s) of the notified document: Direktif untuk 
penilaian laporan pemeriksaan pusat kajian bioekuivalens (BE) bagi pendaftaran produk dan 
notifikasi kajian BE. (4 pages, in Malay) 
6. Description of content: The directive describes that all bioequivalence studies used in 
supporting the registration of generic products in Malaysia shall be conducted in BE 
(Bioequivalence) centres which are inspected by the National Pharmaceutical Control Bureau (NPCB) and listed in the NP CB BE Centre Compliance Programme.  
The exception to this requirement are BE cent res located in the USA, Canada and Europe. 
The following BE inspection reports may be considered by the NPCB if the following criteria are met: 
1. For BE centres located in the USA and Canada – Inspection reports by the USFDA 
2. For BE centres located in Europe and Canada – Inspection reports by the EMA or 
competent authority from individual EU member states depending on the scope of inspection 
BE studies from these facilities may be used to support the registration of generic products 
in Malaysia provided that the inspection report from the competent authorities mentioned in the criteria above is found to be satisfactory by the NPCB. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: To ensure quality, safety and efficacy of pharmaceutical products.  G/TBT/N/MYS/66 
 
- 2 - 
 
  8. Relevant documents:  
1. Control of Drugs and Cosmetics Regulations 1984 (Revised 2006) 
2. Sales of Drugs Act (Act 368) 1952 (Revised 1989) 
3. Malaysian Guideline for Bioequivalence Inspection (October 2014), published by 
National Pharmaceutical Control Bureau, Ministry of Health Malaysia 
4. Drug Registration Guidance Document (September 2011), published by National 
Pharmaceutical Control Bureau, Ministry of Health Malaysia 
9. Proposed date of adoption: 1 July 2016 
Proposed date of entry into force: 1 July 2016 
10. Final date for comments: 60 days from notification 
11. Texts available from: Nati onal enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
National Pharmaceutical Control Bureau 
Ministry of Health 
Lot 36, Jalan Universiti 46200 Petaling Jaya 
Selangor 
Phone: (+603)78835400 Fax: (+603)79551030 
Email: karlsal@bpfk.gov.my   
Website: http://portal.bpfk.gov.my/   
https://members. wto.org/crnattachments/2016/TBT/MYS/16_0719_00_x.pdf