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Berita Ubat-ubatan
November 1998
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Seminar on Pharmacovigilance
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Mandatory ADR Reporting of New Chemical Entities
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Nifedipine – Induced Hypotensive Shock
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Licensing – Ten Years of Implementation
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Stage I Application Form Amended (434.1)
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Comparative Dissolution Performance of Locally Available Piroxicam Products
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Clinical Trials
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New Chemical Entity Approved For Marketing In Malaysia
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New Indications Approved For Registration
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International Visitors and Delegation
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NPCB – Contact Person

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Mandatory ADR Reporting for New Chemical Entities

At its 95th meeting in August 1998, the DCA approved the recommendations of the MADRAC that registration of NCE’s be subjected to the following conditions:-

 

1. Spontaneous ADR Reports occuring in Malaysia.
2. Spontaneous ADR Reports occuring outside of Malaysia.
3. Clinical Trial Adverse Events/Reaction Reports.