Asia-Pacific Roundup: Philippine FDA seeks feedback on standardizing pharma licensing info
The Philippine Food and Drug Administration (FDA) is holding a consultation into plans to update and standardize the contents of the License to Operate (LTO) for pharmaceutical establishments.FDA’s draft guidance applies to establishments including pharma manufacturers, sponsors, and contract research organizations (CROs). Philippine regulations require such establishments to receive an LTO before they can apply for product authorizations or engage in any FDA-regulated activities involving health products. FDA updated the rules, requirements, and procedures for LTO applications in 2024.
The agency said its latest draft guidance updates the LTO's content to reflect current regulatory requirements, improve the clarity and transparency of information in the files, and ensure compliance with the 2024 revision.
FDA framed the updated content requirements as part of its push to strengthen institutional efficiency through the implementation of a robust quality management system. The agency is pursuing that agenda to support its ambition to join the Pharmaceutical Inspection Co-operation Scheme and become a World Health Organization (WHO) Listed Authority.
The international standards strongly recommend a standardized format and content for pharmaceutical manufacturing authorizations, FDA said. By meeting the recommendation, the agency aims to ensure consistency, transparency, and proper monitoring across all issued licenses, while facilitating compliance with internationally accepted practices and promoting ease of verification by local and foreign agencies.
Pursuing the goals, the agency has drafted three LTO content lists. The lists cover the information that should be in licenses for three groups: pharmaceutical establishments; pharmaceutical traders, CROs, and sponsors; and pharmaceutical outlets such as drugstores.
Most of the information fields are found on every list, which all cover details such as the name of the establishment, the LTO number, and the validity of the license. Information fields specific to the LTO for manufacturers include product lines, examples of qualified personnel, and the GPS coordinates for the company’s office.
Every establishment should display the LTO in a conspicuous area, FDA said, and make it available on request by authorized stakeholders and regulatory or enforcement authorities. The agency said any change from the information in an LTO necessitates seeking a new license, regardless of how long the original paperwork is valid. The requirement ensures all regulatory records are up to date.
FDA is accepting feedback on the draft until 24 April.
FDA Consultation
Japan’s PMDA shares guidance on clinical development of PSMA radiopharmaceuticals
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has shared points to consider in the clinical development of certain radiopharmaceuticals.
As part of its “early consideration” series, PMDA has published advice for developers of prostate-specific membrane antigen-targeted positron emission tomography (PSMA-PET) products. PMDA said foreign clinical practice guidelines recommend PSMA-PET as a major imaging modality, reflecting evidence that it is better than other approaches to the initial staging and detection of recurrent prostate cancer.
Based on progress overseas, PMDA said early adoption of PSMA-PET in clinical practice in Japan was expected. However, Japan has yet to approve a PSMA-PET radiopharmaceutical for the initial staging and detection of biochemically recurrent prostate cancer.
PMDA’s guidance is intended to facilitate the Japanese launches of products approved in Europe or the US. The agency said the verification of diagnostic performance based on sensitivity and specificity is generally required for approval in Japan.
However, European and US authorities approved some PSMA-PET diagnostics based on exploratory evaluations of sensitivity and specificity. PMDA may consider that such products have shown a certain level of performance through accumulated experience if they have been on the market for a certain period of time and are recommended as a major imaging modality in foreign clinical practice guidelines.
The agency said it may be acceptable to evaluate efficacy and safety in Japanese patients primarily based on foreign clinical trial data. Foreign data could be acceptable if no clinically significant differences in pharmacokinetics between Japanese and non-Japanese populations are identified.
PSMA-PET products may be eligible for conditional approval. PMDA encouraged sponsors to request a consultation to discuss the pathway. The agency recommended companies entering the market ask image readers in Japanese clinical settings to evaluate scans captured in foreign clinical trials. PMDA wants companies to use the Japanese evaluations to inform local training materials.
PMDA Guidance
Malaysia’s NPRA abolishes mandatory use of analytical tests for animal-derived materials
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has eliminated the need to use validated analytical tests to confirm the absence of animal-derived materials in finished products.
In 2023, NPRA told manufacturers to use DNA testing by PCR or any qualified and validated analytical method to check for animal-derived materials in finished products. At a meeting this month, Malaysia’s Drug Control Authority agreed to remove the mandatory requirement. Applicants must still confirm the presence or absence of animal materials but now have more ways to generate the evidence.
NPRA will assess product-specific supporting scientific evidence, which can include a detailed description of the validated purification processes used to remove animal-derived materials. Companies can choose to use PCR tests for DNA to check for animal-derived materials but no longer have to.
The agency used the update to add that a clear declaration of the specific animal source on the product label is mandatory, regardless of the scientific evidence provided. The requirement applies even if a DNA or analytical test shows there are no animal-derived materials in the finished product. Companies that have negative test results can add a supplementary label statement about the findings.
NPRA has immediately implemented the new rules for products currently under evaluation and for all future filings. The agency repealed the 2023 guidance and another document on the topic it published in 2024.
NPRA Notice
Malaysia’s MDA joins WHO collaborative registration procedure for prequalified IVDs
Malaysia’s Medical Device Authority (MDA) has joined a collaboration for registering WHO-prequalified in vitro diagnostics (IVDs).
WHO’s collaborative registration procedure (CRP) is a reliance-based regulatory mechanism designed to accelerate access to IVDs. Countries use WHO prequalification assessments to inform the registration of IVDs, reducing duplicative regulatory work and ensuring timely access to quality-assured diagnostics.
MDA said companies that use the new pathway need to comply with its regulatory requirements and submission procedures, plus the relevant rules of the CRP. Manufacturers must give written consent for WHO to share confidential assessment reports with MDA and submit an expression of interest before applying for Malaysian registration via CRP.
Countries participating in CRP aim to complete regulatory review within 90 working days of receiving all relevant information from WHO.
MDA Notice
Roche partners with Indian research university on regulatory affairs certificate program
Roche Pharma India plans to support a certificate program in regulatory affairs for students and industry professionals.
The program is covered by a memorandum of understanding that Roche signed with the National Institute of Pharmaceutical Education and Research Raebareli (NIPER Raebareli). Under the agreement, Roche and the Indian public research university plan to advance pharmaceutical education and research in India by bridging the gap between academic learning and real-world industry practices.
As well as the certificate program, Roche and NIPER Raebareli plan to collaborate on a series of guest lectures by industry experts on emerging trends. The collaboration is part of a push to strengthen India’s regulatory science capabilities, which the government has identified as a way to gain a sustained global competitive advantage.
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