Description: D:\ACIS\Web\ACISSB\public_html\images\img01.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\img02.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\img03.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\but_aboutus_off.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\but_services_off.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\but_training_off.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\but_links_off.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\but_contactus_off.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\but_gallery_off.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\img09.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\but_home_off.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\but_sitemap_off.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\h101.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\h102.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\h003.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\bxlr01a.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\bxlr02.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\bxlr03.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\bx02.jpg

 

 

 

 

International Good Manufacturing Practice Training Program Year 2013

Many modules will be available for those hungry for knowledge.

Check out the full module by visiting www.bpfk.gov.my.  Book early to get the lowest rate.

Ë

Fee:

• RM 2450 per module for MOPI members
• RM 2750 per module for non-MOPI members

Take opportunity to learn in-depth on GMP in this special training program.

 

 

The above are early bird rates

 

NATIONAL REGULATORY CONFERENCE

 

Update on developments and challenges in the evolving regulatory landscape of Malaysia .

This conference is strongly backed by the National Pharmaceutical Control Bureau, Ministry of Health, Malaysia.

 

Date: 07 to 09 May, 2013                          Venue: Istana Hotel, Kuala Lumpur  

 

For further information, please click here.

For registration, contact  Lee Sing Chet, tel: +603-78018460, fax: +603 79567151 or email to singchet@bpfk.gov.my  

 

 

MORE Good training programs coming up at Singapore. See below.

 

GMP Training program by Seer Pharma in Singapore

 

·          Do you know that Seer Pharma regularly conducts GMP training in Singapore?

·          There are numerous GMP training modules to choose from. Check the website as stated below.

 

Ø  Registration fee: For MDIS member: S$ 1,444.50 (includes 7% GST)      [ MDIS is Management Development Institute

                                 For Non MDIS member: S$ 1,606 (includes 7% GST)     of Singapore]

 

For more details, please go to www.seerpharma.com , or call (65) 6247 9111 / 6372 1000, or fax to (65) 6796 7788.

You can also email: bioscience@mdis.edu.sg    

 

 

 

NEWS FROM NATIONAL PHARMACEUTICAL CONTROL BUREAU

 

Identification test for Burkholderia cepacia in liquid pharma and herbal products from 01 Jan 2013.

 

From 01 Jan, 2013, NPCB will require that identification test for this organism be done for liquid pharma and herbal products. Click here for more details.

 

GMP will be compulsory for Veterinary medicines from Jan 2012

 

Starting 01-Jan-2012, NPCB requires GMP certification for all manufacturers of veterinary medicines. Registration of sterile products requires GMP certification. NPCB allows registration of non-sterile products before Jan 2012. However, after Jan 2012, these products will be de-registered if the manufacturers fail to obtain the required GMP certification.

For more details (in Malay), click here.

 

 

QUEST3

 

Starting 01-July-2010, QUEST3 is also operational for Herbal/Traditional products, Non-prescriptive OTC, Health supplements and Cosmetic products. It is also operational for matters pertaining to Manufacturing and Import license, as well as Clinical Trial Import License (CTIL).

For more details (in Malay), click here, and here

 

 

Medicinal foot patch

 

In their recent meeting, DCA has announced that all foot patch or foot pads, with medicinal and therapeutic values are to be registered under drugs.  Previously it was categorized as a Medical Device. Product owners to take action and register them asap.

 

Details of this instruction as in the circular attached.

 

 

Honey mixed with herbs

 

In another circular, DCA has announced that all products containing honey and herbs are registrable. Product owners to take action and register them asap. Exemptions are for pure honey, or honey mixed in food products, such as cereals, sweets and biscuits.

 

Details of this instruction as in the circular attached.

 

 

Limit of Lovastatin from natural source

 

NPCB has limit the amount of lovastatin from Red Yeast Rice (Monascus purpureus) to not more than 1% w/w.

 

Details of this instruction as in the circular attached.

 

 

Rejection of Products Registration Submission

 

 

DCA, in its 205th meeting on 29-Mei-2008, has laid down a policy on late replies by applicants for product registration.

 

 

The mechanisms are as follows:

 

 

§   90 days is given for additional or supporting data from date of request

 

 

§   First warning will be given if applicant fails to respond after 90 days from the first request by DCA.

 

 

§   Second warning  will be given 60 days after the first warning.

 

 

§   If applicant fails to respond after 30 days of the Second warning, the application will be presented to the DCA meeting for rejection.

 

 

§   Click here for the circular (in Malay) >>>>>  DCA circular Ref. Bil(08) dlm. BPFK/PPP/01/03

 

 

 

 

Registration of Veterinary medicinal products

 

 

The registration of existing Veterinary medicinal products has been extended to 30-June 2009 for product containing schedule poisons and for non-prescription products.

 

 

It is also good to know that the processing fee has been reduced to RM 1,500 for prescription, non-prescription and health supplement products, while the fee will be RM 1,200 for herbal/natural products.

 

 

Click here to know more. (Note that it’s in Malay language)

 

 

 

 

!

Gamma radiation of finished products

 

 

I guess this is common only among herbal/traditional medicines manufacturer……  Please take note that NPCB DO NOT APPROVE of such practices. Products must be manufactured in a clean, hygiene and GMP compliant to ensure the risk from microbial contamination is minimal.

 

 

NPCB warned that actions can be taken on those who continue to submit their finished goods to gamma radiation.

 

 

For the circular (in Malay), please click here.

 

 

 Other news from National Pharmaceutical Control Bureau (NPCB)

 

 

Ø  Beginning 1 Jan 2010, BPFK would require all registration holders / Manufacturers to follow the microbial specification as stated in the Harmonized Method of testing. Click here for details.  

Ø  Note that NPCB has imposed a new structure for its charges on GMP audit, as follows:

§   For one day audit: RM 1,000

§   For more than one day audit: RM 1,000 per person per day

§   For audit more than 3 days audit or more than 3 man-day: RM 10,000 (max charge)

§   For foreign (overseas) audit: € 5,000

For more details, please refer to the circular (in Malay): (08) dlm. BPFK/30/8 Bhg. 9 dated 02 Jan 2008

Ø  Cosmetic products will require Notification instead of registration w.e.f. 01 Jan 2008.
Registration of Cosmetic products will cease to apply after 30 Nov 2007. Notification only commence from 01 Jan 2008.

Ø  Contact officials of the Cosmetic division, NPCB, for more details. Tel. +603-7957 3611.

Ø  Click here for the official circular Ref. KKM-55/201/005/01 (1) dated 26 Dec. 2007 (in Malay language)

Ø  The use of premix is now disallowed by NPCB for product formulation of traditional / herbal medicines. Please refer to NPCB circular, Ref. (71) dlm. BPFK/02/5/1.3 dated 01 Jun 2007 for more details. Existing product licensed holders have up to 6 months to amend their product formulation to ‘single blended herbs’

 

 

Ø The Drug Control Authority (DCA) now requires report on Process Validation, other than Test Method Validation, for submission of pharmaceutical product registration. Refer to circular Ref. (69) dlm. BPFK/02/5/1.3 dated 08 Jan 2007 for more details. Dateline as follows:

·      Injectables (sterile products): already enforced

·      Galenicals (Internal & External preparations):  w.e.f. 01 July 2007

·      Tablets, Capsules & others: w.e.f. 01 January 2008

 

 

Ø  Take note! (NPCB) will introduce a new guideline on Good Lab Practise (GLP). Go to the web site www.bpfk.gov.my and download your copy.

 

 

 

 

 

 For details and more circulars, please go to http://www.bpfk.gov.my/ and download the relevant circulars attached.

Description: D:\ACIS\Web\ACISSB\public_html\images\bx04.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\bxlr04.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\bxlr05.jpg

Description: D:\ACIS\Web\ACISSB\public_html\images\bxlr06.jpg

 

 

Privacy Policy | Terms of Use | Sitemap

A1 Consultancy & Integrated Services Sdn Bhd ® 2006 Designed by Web Channel PROductions.