How does the Malaysian Orphan Medicines Guideline 2020 expedite drug approval?

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The Malaysian Orphan Medicines Guideline 2020 Expedites Drug Approval by Establishing Clear Evaluation Procedures and Criteria

The Malaysian Orphan Medicines Guideline 2020 facilitates the swifter registration of new medicines for rare diseases by outlining specific procedures and criteria for their evaluation. Adherence to these established guidelines has demonstrably contributed to the accelerated approval of safe and effective treatments for patients in Malaysia.
Streamlined Evaluation Framework

The guideline introduced a structured approach to assessing new orphan medicines, which includes defining the necessary procedures and specific criteria for evaluation. This framework provides a clear pathway for drug manufacturers to follow, thereby reducing ambiguity and potential delays in the review process. By setting out these parameters in advance, the Ministry of Health (MOH) ensures that all necessary aspects are considered efficiently.
Facilitation of Safe and Effective Medicine Approvals

Compliance with the Malaysian Orphan Medicines Guideline 2020 has been instrumental in expediting the approval of medicines that meet stringent safety and efficacy standards. This streamlined process allows critically needed treatments for rare diseases to reach patients more quickly, a significant improvement from the situation prior to 2020 when no such medicines were registered. As of April this year, 26 medicines for rare diseases have been registered, a milestone attributed to the effectiveness of these guidelines.
Context of Rare Disease Management in Malaysia

The introduction of the guideline in 2020 is part of broader efforts by the Malaysian government to improve access to medicines and treatment for individuals with rare diseases. These initiatives also include the identification and inclusion of 529 types of rare diseases in the Malaysian Rare Disease List, with approximately 80 per cent being genetic in origin. Furthermore, the annual allocation for the diagnosis and treatment of rare diseases has seen an increase, and a National Rare Disease Policy is being developed.

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How does the Malaysian Orphan Medicines Guideline 2020 expedite drug approval?

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