WARNING TO HOLDERS/MANUFACTURERS OF MEDICINES AGAINST MAKING UNAPPROVED CHANGES THAT AFFECT THEIR QUALITY AND EFFICACY
Generic medicines contain the same active ingredient and are indicated for the same use as the innovator medicines and therefore must be the same in all respects to ensure that they can be used interchangeably.
As generic medicines contain well documented active ingredients, it is the global practice to accept bioequivalence studies in lieu of clinical trials as proof of quality and efficacy. The Ministry of Health has made the conduct of bioequivalence studies on generic medicines a mandatory requirement since 1999 and to date, there are 112 active ingredients for which bioequivalence studies are required as a pre-requisite for registration.
Bioequivalence studies are conducted to compare generic medicines against innovator medicine using human volunteers as study subjects to prove that the generic medicines are equivalent to the innovator medicine in terms of providing the same therapeutic effects to the patients. In view of the importance of bioequivalence studies to the effectiveness of generic medicines, the DCA has always taken serious view on matters related to this requirement. Since its implementation, a total of 213 registered medicines have been cancelled and suspended due to failure to comply with this requirement. In 2008 and 2009, DCA has rejected a total of 66 new applications for registration because the applicants failed to submit adequate and satisfactory bioequivalence study data.
After a medicine has been registered with the DCA, it is possible that the manufacturer may make some changes on the source of active ingredients used, manufacturing process involved and so on. As all these changes may have implications on the quality and efficacy of the registered product, it is mandatory for companies to seek prior approval from the DCA before making any changes to these registered products. Data must be provided to substantiate that the quality, efficacy and safety is not compromised through these changes. Punitive actions can be taken against any companies that do not conform to these requirements/directives.
All registration holders and manufacturers of medicines are again reminded to ensure that medicines being marketed are in accordance with the formulation, quality standards and regulatory requirements as specified and approved by DCA. Any modifications to the product that can affect the quality of the medicines are not allowed and prior approval must be sought from the DCA before any critical changes are made.
In order to ensure that all marketed medicines in Malaysia comply with these regulatory requirements, all registered medicines are continuously monitored through the Post-Market Surveillance Program and the Adverse Reactions Reporting Program. The DCA wishes to bring to the attention of all registration holders and manufacturers that it will not hesitate to suspend or cancel the registration of any unsafe or substandard medicines apart from instituting immediate recalls of such products.
All registration holders and manufacturers of medicines are again reminded to ensure that medicines being marketed are in accordance with the formulation, quality standards and regulatory requirements as specified and approved by DCA. Any modifications to the product that can affect the quality of the medicines are not allowed and prior approval must be sought from the DCA before any critical changes are made.
In order to ensure that all marketed medicines in Malaysia comply with these regulatory requirements, all registered medicines are continuously monitored through the Post-Market Surveillance Program and the Adverse Reactions Reporting Program. The DCA wishes to bring to the attention of all registration holders and manufacturers that it will not hesitate to suspend or cancel the registration of any unsafe or substandard medicines apart from instituting immediate recalls of such products.
The DCA wishes to bring to the attention of all medical practioners, health professionals, consumers and the public that they can report directly to DCA of any complaints regarding the quality of medicines particularly if they experience adverse reactions or any other problems with these medicines.
Director General of Health
as Chairman of the Drug Control Authority
Ministry of Health Malaysia
Jan 2010
retrieved from www.pharmacy.gov.my
Director General of Health
as Chairman of the Drug Control Authority
Ministry of Health Malaysia
Jan 2010
retrieved from www.pharmacy.gov.my
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