Asia-Pacific Roundup: Medsafe cuts time to complete initial application evaluations

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) reduced the time taken to complete the initial evaluation of applications in its most recent financial year, achieving its goal more consistently than in the previous year.

Medsafe seeks to complete the initial evaluation of higher-risk applications within 150 working days, but only did so 58% of the time during its last financial year, which ended in June 2023. The mean time to finish the initial review was 153 days.

The agency improved both figures in the financial year ended June 2024, achieving its goal 82% of the time in a mean processing time of 112 days. The data cover applications that were completed, but not necessarily received, in the 12-month reporting period.

The improvements are part of a wider reduction in processing times. The mean time for completing initial evaluations fell for 8 of the 12 types of application. The time was unchanged — and below the target — for lower-risk L1 applications. There were no data for the previous financial year for the recently introduced lower-risk L2 and L3 categories.

Completion times increased for intermediate-risk applications, rising from 130 days to 140 days, although the percentage of tasks finished on time improved slightly, from 81% to 83%. In the remaining categories, the mean completion time fell and the percentage of tasks finished by the deadline increased or was unchanged.

There is still room to improve, particularly in the handling of abbreviated applications. The mean time for completing abbreviated initial evaluations of higher-risk applications fell from 128 days to 117 days. The figures for abbreviated initial evaluations of intermediate-risk applications were 115 days and 85 days.

In both cases, the mean time is above the 75-day turnaround targeted by Medsafe. The agency met the deadline for 36% of higher-risk abbreviated applications, up from 21% the previous year, and for 40% of intermediate-risk applications, up from 19%.

Medsafe also reduced the time to application consent for most types of submission. Total time, which includes steps taken by the applicant, also fell for most of the filing types. The agency highlighted 25% and 44%, respectively, reductions in the time to application for higher-risk and intermediate-risk abbreviated applications.

Medsafe Report

Pakistan’s DRAP posts draft guidance on locally manufactured biological products

The Drug Regulatory Authority of Pakistan (DRAP) is seeking feedback on draft guidance for companies that intend to apply for authorization of locally manufactured biological drug products.

DRAP has drafted the document to help manufacturers develop registration applications using Form-5F, which companies use to prepare submission dossiers based on the common technical document format. The draft guidance provides general instructions intended to ensure complete, usable submissions for biological drugs in their “concentrated form” and “finished form.”

In the section on drugs in their concentrated or ready-to-fill form, DRAP says companies should provide a legalized good manufacturing practice certificate “of biological drug substance manufacturer abroad (who will provide concentrate/ready to fill bulk of biological drug to Pakistani manufacturers for further processing) as an evidence that the manufacturer is an authorized manufacturer of biological drug in the country of origin.” DRAP is requesting a legalized free sale certificate, too.

The section also covers the need to provide complete biosimilarity studies of the finished product “of same source (bulk concentrate or ready to fill) manufactured either from country of origin or by any reference regulatory authority as adopted by Registration Board to demonstrate the biosimilarity.” The provision of the lot release certificate of the finished product manufactured is another requirement.

Those requirements are part of a 14-point section on drugs in their concentrated or ready-to-fill form. A section on “biological drugs (finished form/naked vials)” features three points, including a requirement for importers to provide the exporter’s biosimilarity studies, covering analytical, animal and clinical data, on the finished product.

The final section covers other manufacturing processes. In that section, DRAP says that “for products where process like PEGylation are performed locally, then complete clinical data shall be required by the manufacturer.”

DRAP shared the draft to receive comments from stakeholders but its statement lacks a deadline for filing feedback. The agency typically accepts comments for 15 days after it uploads a draft document.

Draft Guidance

Asian regulators mark #MedSafetyWeek campaign with safe drug use activities

Regulatory agencies in India, Malaysia, New Zealand and the Philippines have participated in the ninth global #MedSafetyWeek campaign to support the safe use of medicines.

This year’s event, which ran from 4-10 November, focused on preventing side effects and reporting adverse events. The National Coordination Centre-Pharmacovigilance Programme of India, part of the Indian Pharmacopoeia Commission, used the event to promote the message that patients play a crucial part in making medicines safer by reporting suspected side effects.

Medsafe echoed the same message and pointed readers to the Centre for Adverse Reactions Monitoring’s online form for reporting suspected side effects. Medsafe also reminded healthcare professionals of the need to take the safety profile of a product into account when prescribing and educating patients on the safe use of their medicine.

Malaysia’s National Pharmaceutical Regulatory Agency and the Philippine Food and Drug Administration also shared details of their #MedSafetyWeek activities. The agencies used social media to publicize ways to prevent and report side effects.

IPC Notice, Medsafe Statement, NPRA Update, FDA Post

AstraZeneca says it will fully cooperate with Chinese authorities if requested

AstraZeneca said it “will fully cooperate with the Chinese authorities,” if requested. The company made the statement in the week that Leon Wang, AstraZeneca China president, was detained by local authorities.

Late in October, AstraZeneca said Wang was under investigation. The company said Wang was cooperating with an ongoing investigation by Chinese authorities, adding that its operations in the country would continue under the current general manager of AstraZeneca China.

Yicai Global, an online publication focusing on China’s business sector, reported that dozens of senior AstraZeneca China executives had been implicated in an ongoing insurance fraud case. That day, AstraZeneca published its statement about cooperating with the authorities and its policy of not commenting on “speculative media reports including those related to ongoing investigations in China.”

The following day, publications including Reuters reported that Wang was in custody. AstraZeneca told Reuters it did not believe the detention of Wang was linked to the health insurance fraud case.
AstraZeneca Statement, Yicai Global, Reuters (paywall)

Other news:

DRAP shared an alert about a falsified human anti-D immunoglobulin product. Hakimsons Impex, a distributor of biological medicines, told the agency about the presence of falsified Rhophylac across Pakistan. DRAP directed its regulatory field force to step up surveillance and confiscate the product. The agency warned falsified injectables can cause lethal adverse effects. DRAP Notice

Asia-Pacific Roundup: Medsafe cuts time to complete initial application evaluations

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