Asia-Pacific Roundup: Malaysia’s NPRA updates regulatory reliance guide, expands pool of reference agencies

The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has updated its guideline on approval pathways for medicines that have already received authorization in certain overseas territories. NPRA’s changes include the addition of new reference regulatory agencies and the shortening of approval timelines.

Malaysian officials published the guideline on the facilitated registration pathway in 2019, setting out options for medicines to come to market via abbreviated and verification review processes. The document listed the European Medicines Agency and US Food and Drug Administration as the reference regulatory agencies. A product approved by one reference agency was eligible for a 120-day abbreviated review. Approval by both reference agencies unlocked a 90-day verification review.

The updated guideline, which will take effect at the start of 2024, features major changes to the facilitated registration pathway. NPRA has added regulatory authorities in Australia, Canada, Japan, Switzerland and the UK to its list of reference agencies. Malaysia may also now rely on Association of Southeast Asian Nations (ASEAN) Joint Assessment decisions, and on the World Health Organization’s (WHO) stringent regulatory authorities’ medicines evaluations.

NPRA has changed the eligibility criteria for facilitated registration. Companies can still apply for an abbreviated review on the basis of an approval by a reference agency, or on the strength of approval via WHO’s collaborative registration procedure. However, verification review is now open to products that come to market via ASEAN Joint Assessment, rather than medicines approved in two reference markets.

During a verification review, NPRA will now perform a “review of the sameness of the product dossier to ensure that the medical product is the same as the one that has been assessed by ASEAN Joint Assessment.” The review will take 30 working days, down from 90 under the old guideline. NPRA has also cut the timeline for abbreviated review from 120 working days to 90 working days. Companies can apply for facilitated registration within three years of approval by a reference agency, up from two years today.

Other changes include the expansion of the scope of the pathway to cover cell and gene therapies, as well as the new drug products, generic medicines and biologics eligible for registration under the old guidelines. NPRA has updated its process and supporting materials too, providing a template for the declaration statement, dossier checklists and flow charts.

NPRA Guidance

Pakistan orders immediate product recall over suspected DEG/EG contamination

The Drug Regulatory Authority of Pakistan (DRAP) has ordered the immediate recall of five syrups and suspensions because of the suspected contamination of one batch with diethylene glycol (DEG) and ethylene glycol (EG).

DRAP took the action in response to suspicions that a single batch of Alergo syrup, a medicine used in the management of flu, cough and fever, is contaminated with DEG and EG. The contaminants, industrial solvents that are wrongly used in place of pharmaceutical grade propylene glycol (PG), have been linked to multiple recalls and the deaths of more than 100 children in recent years.

The Maldives Food and Drug Administration (MFDA) recently banned the import, sales and use of Alergo after detecting DEG and EG in a batch. Since the syrup is manufactured by Pharmix Laboratories, a company based in Lahore, Pakistan, the MFDA ban triggered a response by DRAP.

While MFDA’s concerns centered on one batch of Alergo, DRAP has ordered the recall of 19 batches of five syrups and suspensions. Syrups and suspensions are susceptible to contamination with DEG and EG because PG is used as an excipient in such formulations. DRAP has told Pharmix to recall the batches, distributors and pharmacists to stop supplying the medicines, and patients to stop using the products.

Local newspaper DAWN reported that the government in Punjab, the region where Pharmix is based, has sealed the manufacturing facility. According to the newspaper, the WHO identified the contaminants in Malaysia and local authorities are starting proceedings against the manufacturer.

DRAP Notice

China’s NMPA vows to strengthen PIC/S cooperation as membership application advances

China’s National Medical Products Administration (NMPA) will strengthen communication and cooperation with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) as it works to join the group.

The Chinese regulatory agency applied to join PIC/S in late September. PIC/S wrote to NMPA in November to confirm its status as an applicant, leading the regulator to publish a statement detailing its intention to strengthen communication and cooperation and other aspects of its preparations to become a member of the scheme.

“NMPA will ... promote itself to become a full member of PIC/S, and take this opportunity to continuously improve the country’s drug inspection system and standards, to constantly enhance its drug inspection quality management system and to steadily promote the development of its inspectors' team, so as to modernize the national drug regulation in China,” NMPA wrote.

Bringing NMPA into PIC/S would address one of the big geographic gaps of the scheme, which has worked to harmonize good manufacturing practice inspection procedures for almost 30 years. Authorities in Europe, Japan, the US and other parts of the world are part of PIC/S. China and India are notable absentees from the list of authorities that participate in PIC/S.

NMPA Notice

TGA issues $480,000 fine over alleged drug promotion through Australian telehealth service

Australia’s Therapeutic Goods Administration (TGA) has fined InstantScripts $742,500 AUD (approximately $487,000 USD) for the alleged unlawful advertising of therapeutic goods. TGA issued 45 infringement notices to the online pharmacy and telehealth consultation provider.

According to TGA, InstantScripts allegedly advertised prescription-only medicines in conjunction with the provision of telehealth services. The allegations center on promotion of the use and supply of medications such as antibiotics, insulin, blood thinners, and blood pressure and cholesterol medications. TGA ruled that the activities breached the prohibition on direct-to-consumer ads for prescription drugs.

InstantScripts is an Australian provider of online healthcare services. According to the company, more than 1 million patients have used its services, which enable the public to request prescriptions and blood tests and consult with physicians remotely.

TGA has ruled that some of the company’s activities have breached its advertising regulations, resulting in one of the larger fines issued by the administration. Officials warned that “advertising directly to consumers could create an inappropriate demand for these medicines by patients and lead to unnecessary or harmful prescribing.”

TGA Notice

Australian authorities cooperate on seizure of unlawfully imported therapeutic goods

TGA has worked with the Australian Border Force (ABF) to seize more than 307,000 units of unlawfully imported medicines and medical devices with an estimated value of more than $2 million AUD (approximately $1.3 million USD).

The seizure included “large amounts of painkillers, anti-cancer medications, erectile dysfunction medications, prescription medications and other medicines with a potential for abuse,” as well as “36kg of border-controlled drugs, including performance and image enhancing drugs, narcotics and benzodiazepines.”

A “significant number” of counterfeit, falsified and substandard medicines were seized. TGA and ABF also removed more than 370 Australian-hosted online advertisements unlawfully promoting therapeutic goods. The actions were part of the global Operation Pangea XVI, which resulted in 72 arrests across 89 countries.

TGA Notice

Other News:

Malaysia’s Medical Device Authority has published an overview of the possible ways to register an in vitro diagnostic analyzer. MDA Notice

Asia-Pacific Roundup: Malaysia’s NPRA updates regulatory reliance guide, expands pool of reference agencies

Related topics

Recommended content

Welcome to the new RAPS Digital Experience