Chow, Wan Lee and Salleh, Nur Afiqah Mohd and Kang, Tse Siang (2024) Access to Innovative Medicines: Regulation Change and Factors Associated with Drug Approval Lag in Malaysia. Therapeutic Innovation & Regulatory Science, 58 (3). pp. 528-538. ISSN 2168-4790, DOI https://doi.org/10.1007/s43441-024-00620-x.
Full text not available from this repository.Abstract
BackgroundDrug approval lag is the time difference for new medicine to obtain marketing authorization approval in the study country compared to the first global approval. Drug approval lag delays the availability of innovative medicine to patients. This may lead to delay in treatment and severe public health implications. The study aimed to determine drug approval lag in Malaysia, the factors associated with drug approval lag (drug characteristics, regulatory factors and applicant type) and the association of the submission lag and review time with the regulation change.MethodsAll new pharmaceutical products approved between January 2015 and March 2021 were examined (n = 136) using publicly available information. Factors associated with drug approval lag were determined using multiple linear regression.ResultsThe median drug approval lag was 855 days. Drug approval lag was associated with drug characteristics and regulatory factors. Median submission lag and median review time for products which fulfilled the requirement for the new regulations (Conditional Registration/ Facilitated Registration Pathway) were shorter compared to products which did not fulfil the requirement.ConclusionDrug approval lag may delay the access of innovative medicine to patients, and this may lead to an increase in morbidity, mortality and healthcare costs. Good Regulatory Practices ensure efficient and transparent regulatory system which support the public health policy objectives in the most efficient way. The new regulations in Malaysia reduced the median submission lag and review time. The findings may be useful for regulators to consider for future policy development for medication access.
| Item Type: | Article |
|---|---|
| Funders: | UNSPECIFIED |
| Uncontrolled Keywords: | Drug lag; Innovative medicine; Regulation; Registration approval |
| Subjects: | R Medicine > R Medicine (General) |
| Divisions: | Faculty of Medicine > Social & Preventive Medicine |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 05 Nov 2024 08:34 |
| Last Modified: | 05 Nov 2024 08:34 |
| URI: | http://eprints.um.edu.my/id/eprint/45589 |
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