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Berita Ubat-ubatan
August 2000
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Regulatory Control Beyond 2000
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Separate Manufacturing Facilities For Cephalosporins
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Warning Label for products - NSAID
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Registration of Products Containing Insect Repellants
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Warning for Products containing Hydroquinone
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Actions To Be Taken Against Products Containing CISAPRIDE (PREPULSID)line.gif (87 bytes)
Licensing Update - June 2000
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The Changing Pharmaceutical and Traditional Medicine Premises Landscape: 1987 - 2000
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Additional Indications Approved for Registered Products
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GMP News
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Quality Control Training Course
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Sources of products registered with DCA As At 30.6.2000
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New Products Approved for Marketing in Malaysia
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NPCB officers to contact
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Clinical Trials

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Separate Manufacturing Facilities For Cephalosporins

At its 113th meeting held on 4th April 2000, the DCA agreed that products containing cephalosporins should be manufactured in a separate area with separate manufacturing facilities. This is to prevent cross contamination between products as well as to safeguard the workers' health and environmental safety.

The implementation of this decision is in accordance with the requirements of the European Commission GMP Guidelines, Eudralex 1997, which is currently being adopted by Malaysia. This is to reflect Malaysia's efforts to reinforce GMP compliance of the local pharmaceutical manufacturers as required by the PIC/S.

The dates for implementing the above decision are as follows:-

  1. For new products (imported/local) containing cephalosporins Effective from April 2000
  2. For existing products containing cephalosporins
    The product registration holder is required to furnish details to indicate that their products are manufactured in a separate area with separate manufacturing facilities by the following dates:-

Imported products - 31st December 2000
Local products - 30th June 2001

After the above mentioned dates, all such products (imported and locally manufactured) which are manufactured in premises which do not comply to the requirements of the DCA will be deregistered.

As at May 2000

  • There are 21 types of cephalosporins registered with the DCA.

  • Total number of registered products which contain cephalosporins is 225, comprising 81 local products and 144 imported products.

  • There are 27 local manufacturers of cephalosporins.

  • These local manufacturers produce 8 types of cephalosporins out of the 21 types registered, namely, Cefoperazone, Cefdinir, Cefaclor Monohydrate, Cefaclor, Cephalexin Monohydrate, Cephalexin, Cefadroxil Monohydrate and Cephradine.