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Access to Innovative Medicines: Regulation Change and Factors Associated with Drug Approval Lag in Malaysia

Chow WL, Salleh NAM, Kang TS

Ther Innov Regul Sci, 2024 May;58(3):528-538.
PMID: 38376698 DOI: 10.1007/s43441-024-00620-x

BACKGROUND: Drug 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.
METHODS: All 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.
RESULTS: The 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.
CONCLUSION: Drug 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.
Asia Core Dossier: Standardizing CMC Requirement to Facilitate Best Case Submissions in Asia

Boobalan J, Sohn KB, Shinawatra O

Ther Innov Regul Sci, 2024 Mar;58(2):223-233.
PMID: 38194164 DOI: 10.1007/s43441-023-00600-7

When the regulatory requirements are converged or harmonized, the country-specific variance of countries is often reduced or omitted, and this facilitates the possibility of preparing a core dossier that caters to multiple countries. When such options of a core dossier are acceptable to multiple countries, the resource required to prepare the dossier and the time taken to prepare it is also reduced, thus eliminating resource constraints in supporting dossier planning and preparation and indirectly facilitating earlier submission in countries. In this paper, the authors have illustrated a process applied to standardize the dossier requirements amongst selected countries in Asia, producing an output of a core dossier that applies to four submission types amongst these countries. The core dossier adopts the International Council for Harmonization-Common Technical Dossier format as a reference. Main focus is the standardization of format and requirements within the Module 3 or Chemistry Manufacturing Controls sections of the dossier, which from the authors' organizational experience usually notes a higher variances and country-specific elements. Development of the dossier standardization process is due to an internal hurdle within the authors' organization, where global resource constraints and prioritizations of dossier preparation and compliance review process needed to be improved to facilitate earlier or near-simultaneously submissions in the majority of the Asia countries. The paper demonstrates an assessment of the dossier components and standardization to assemble a fit-for-purpose core dossier termed 'Asia Core Dossier' (ACD). ACD has been successfully implemented within the authors' organization to reduce country-specific requirements and facilitate earlier (fit for strategy) submissions in the selected Asia countries. The paper also discusses the tangible benefits of the authors' experiences from utilizing the ACD. Regulatory professionals in different organizations could reference the ACD as a template for preparing a simplified and efficient dossier and as a relevant component of Good Submission Practice (GSubP).
Fulltext An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology

Sani NM, McAuslane N, Kasbon SH, Ahmad R, Yusof FAM, Patel P

Ther Innov Regul Sci, 2020 Sep;54(5):1215-1224.
PMID: 32865804 DOI: 10.1007/s43441-020-00140-4

INTRODUCTION: The National Pharmaceutical Regulatory Agency (NPRA) embarked on a regulatory-strengthening program and is evaluating its processes. Optimising Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that provides benchmarking data that can define performance targets and focus performance improvement. The objective of this study was to use OpERA methodology to determine where time is spent in the NPRA approval process and to form a baseline to measure the performance improvements.
METHODS: The OpERA tool was used to collect specific milestone data that identify time periods, review stages, and data points for new active substances and biosimilars approved by NPRA in 2017.
RESULTS: In 2017, 25 new active substances and 1 biosimilar were approved by NPRA in a median of 515 days, representing both agency and applicant time. The median time between dossier receipt and the initiation of NPRA scientific assessment was 135 days, but there was a wide variation in queuing time. The median total assessment time was 279 days (agency and applicant timing). NPRA took a median of 166 days; applicants took a median of 131 days to respond to deficiency questions, with up to 6 cycles of review required for approval and 65% of applications requiring 4-5 cycles to provide satisfactory responses.
CONCLUSIONS: As a result of these data, NPRA proposes three improvements: target start for scientific assessment 100 days after file acceptance, a maximum of 5 review cycles, and applicant response time limited to 6 months. These results will serve as a baseline for further assessment.
Fulltext Materiovigilance in Perspective: Understanding Its Concept and Practice in the Global Healthcare System

Sapkota B, Palaian S, Shrestha S, Ibrahim MIM

Ther Innov Regul Sci, 2023 Jul;57(4):886-898.
PMID: 37106236 DOI: 10.1007/s43441-023-00514-4

Materiovigilance (Mv) has the same purpose and approach in ensuring patient safety as pharmacovigilance but deals with medical devices associated with adverse events (MDAEs) and their monitoring. Mv has been instrumental in recalling many defective or malfunctioning devices based on their safety data. All MDAEs, such as critical or non-critical, known, or unknown, those with inadequate or incomplete specifications, and frequent or rare events should be reported and evaluated. Mv helps to improve medical devices' design and efficiency profile and avoid device-related complications and associated failures. It alerts consumers and health professionals regarding counterfeit or substandard devices. Common events reported through Mv are device breakage and malfunction, entry- and exit-site infections, organ perforations or injuries, need for surgery and even death, and life cycle assessment of devices. Health authorities globally have developed reporting frameworks with timeframes for MDAEs, such as MedWatch in the USA, MedSafe in New Zealand, and others. Health professionals and consumers need to be made aware of the significance of Mv in ensuring the safe use of medical devices and getting familiar with the reporting procedures and action plans in case of a device-induced adverse event.