Asia-Pacific Roundup: Malaysia’s NPRA to start 1-year pilot of new variation application timelines

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) is preparing to trial new timelines for variation applications to “provide greater clarity and more effective monitoring.”

NPRA published timelines for applications to amend the authorizations of existing pharmaceutical and biological products in 2022 and 2017, respectively. The biologicals document established review periods ranging from 30 to 90 working days, depending on the nature of the variation. The pharmaceutical text stated that grouped variation applications would take up to 80 or 100 working days to review, depending on whether they included requests for major changes.

Starting on 1 June, NPRA will pilot new harmonized timelines for pharmaceutical and biological products. NPRA will aim to review groups of up to five “do and tell” minor variations per registered product within 35 working days. The agency may extend the review time if the applicant submits more than five minor do and tell variations.

NPRA has set an 80 working day target for reviewing minor variation-prior approval applications for biological and pharmaceutical products. Again, applicants can submit up to five variations per product and NPRA may extend the timeline if they include more submissions. The 80-day timeline applies to the new category under minor variation-prior approval on safety-related changes.

The new turnaround time for major variations is 120 working days. NPRA is targeting that timeline for submissions that include a maximum of three major variations. Applicants can also group a maximum of three major variations in a bundle of up to five variations of any type. NPRA will take up to 150 working days to review such a bundle application. The agency will extend the timeline if the bundle exceeds the limits on the numbers of variations.

NPRA is also trialing times for replying to product registration holders. The agency plans to take up to 45 working days to respond to minor variations and up to 60 working days to reply to submissions that include major variations.

Applicants must attach a cover letter that summarizes the changes for each variation application. NPRA expects applicants to include information such as the proposed variation category, a brief description of the proposed variation with justification and, if available, approvals from the country of origin's national regulatory agency or reference agencies.

NPRA’s one-year pilot also includes new timelines for natural and health supplement products.

NPRA Notice

Philippine FDA starts trialing electronic certificate of product registration system

The Philippine Food and Drug Administration (FDA) is piloting an electronic certificate of product registration (E-CPR) information system for applications for initial authorization of generic medicines.

As part of the FDA eServices Portal, E-CPR will act as a platform for end-to-end processing of applications for initial registration of generic prescription drugs for human use. FDA said the system “integrates streamlined procedures, automated tracking of application status and release of electronic communications and authorizations to applicants into one system.”

The agency began a pilot implementation of the system last week. FDA will end the pilot on 7 August. During the testing period, the agency wants all companies applying for initial registration of generic prescription human drugs to make their submissions using the eServices Portal.

FDA has canceled previous applications for initial registration of generic prescription drugs for human use that were pending for submission of documents for pre-assessment to the Food and Drug Action Center or pending for pre-assessment. Affected applicants should file through the portal. Applicants with acceptable pre-assessment results will be processed under the manual evaluation procedure.

The agency has provided an overview of the application and review process for the E-CPR pilot test. The documents required for registration and the turnaround times for processing applications are based on the existing rules and regulations.

FDA Notice

PMDA shares analysis of clinical data packages for biosimilars approved in Japan

A team at Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published an analysis of the clinical data packages for authorized biosimilars in the journal Pharmaceutical Medicine.

The researchers reviewed the size and nature of the clinical data packages used to support approvals of biosimilars from 2009 to 2023. The analysis showed PMDA had approved 24 biosimilars based on the comparative pharmacokinetic (PK) and efficacy studies; 10 biosimilars based on the comparative PK and pharmacodynamic (PD) study; and one biosimilar based on the comparative efficacy study.

Almost 70% of comparative PK studies enrolled up to 100 healthy volunteers or patients, although some recruited up to 300 participants. Around half of comparative PD studies enrolled 31 to 60 cases, with the rest split evenly between studies of one to 30 and 61 to 90 participants.

Forty percent of comparative efficacy studies enrolled 601 to 900 subjects. Oncology and rheumatology trials were the most common studies of that size. A similar proportion of comparative efficacy studies enrolled 301 to 600 people, with the remaining trials recruiting 300 or fewer subjects.

The PMDA researchers concluded that “efficient biosimilar development should be considered on the basis of the accumulation of scientific understanding of comparable features of biosimilars and their development.”

PMDA Paper

Singapore and Malaysia ink deal to cooperate on pharmaceutical product regulation

Health authorities in Singapore and Malaysia have signed a memorandum of understanding (MOU) to support continued cooperation on the regulation of pharmaceutical products.

Singapore's Health Sciences Authority (HSA) first signed a MOU with the Ministry of Health of Malaysia in 2012. That agreement formalized ties between the authorities and positioned them to cooperate in areas such as regulatory science, postmarket vigilance and good clinical practices. Specific activities included joint audits and the exchange of medical product registration assessment reports.

HSA said the renewal of the agreement “marks an important milestone in solidifying ties between the two regulatory authorities.” Postmarket vigilance, enforcement and good clinical practice remain focal points of the cooperation.

HSA Notice

TGA fines Australian manufacturer after inspectors find unacceptable practices

Australia’s Therapeutic Goods Administration (TGA) has fined a manufacturer of products used in diagnostic imaging for allegedly breaching the conditions of its license.

TGA issued infringement notices totaling AU$ 37,560 ($24,770) after inspecting Radpharm Scientific, a manufacturer of cold kit radiopharmaceuticals and sterile saline vials used in diagnostic imaging. The good manufacturing practice inspection of Radpharm found “unacceptable manufacturing practices that presented a risk of unsafe products being supplied,” TGA said.

“The infringement notices were issued due to the seriousness of the breaches and for not taking appropriate steps to investigate and address manufacturing failures.” TGA said. “The affected batches are no longer in supply and there have been no reports of adverse events associated with their use.”

TGA is working with Radpharm to develop and implement effective preventative measures to address the inspection findings. The agency used the notice to remind manufacturers of the need to investigate serious issues to prevent recurrence. TGA said it may take regulatory actions in response to “repeated poor compliance.”

TGA Notice

Other News:

The Medical Devices Authority (MDA) has established a new procedure for trading medical devices with countries that lack diplomatic relations with Malaysia. Companies need to obtain a license for import or export and apply for medical device registration to overcome the trade restrictions. The policy is now in effect. MDA Notice (Malay)

Asia-Pacific Roundup: Malaysia’s NPRA to start 1-year pilot of new variation application timelines

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