Asia-Pacific Roundup: Philippine FDA responds to feedback on drug and API exports

The Philippine Food and Drug Administration (FDA) has published the outcome of its consultation on the registration of drug products and active pharmaceutical ingredients (APIs) intended solely for export.

FDA released a draft document for consultation in March. The text applied to pharmaceutical products and drug substances wholly manufactured in the Philippines but solely intended for sale and use outside the country. FDA used the guidance to establish eligibility criteria, documentary requirements, and other rules for export-only products (RELATED: Asia-Pacific Roundup, Regulatory Focus, 25 March 2024). The agency published the feedback and its responses last week.

One respondent asked FDA to delete “wholly” in the description of where the products are manufactured. Another respondent suggested deleting a paragraph that excludes products made abroad, imported into the Philippines, and re-exported because any “activity done by local manufacturers for export is beneficial.” The respondent said there is “no compelling reason” to limit what products are exported.

FDA pushed back against the proposals, explaining that it is necessary to restrict the pathway to products wholly manufactured in the Philippines to prevent abuse of the process. Without the restriction, a drug company could import a partially made product with minimal manufacturing activities in the Philippines to avoid stringent evaluation in the country of origin.

“Evaluation of export-only applications is limited to ensuring that the manufacturer is licensed and GMP certified. There is no evaluation of the starting materials and its manufacturing details,” FDA said. “Hence, FDA will not be able to properly evaluate a product’s manufacture if it is already partially manufactured when imported and is also, therefore, not in line with the principle of the Tatak Pinoy Act.”

The agency also clarified that the rules apply to drug substances, which the final text more prominently refers to as active pharmaceutical ingredients, and explained that it would prioritize registering products and APIs sold locally when there is a critical shortage.

Another respondent recommended removing lines about the need for the holder of an export-only authorization to notify FDA when it exports a product, arguing that “pertinent information is already reflected upon application,” making notification redundant. FDA took a different position.

“Proposed export-only authorization is not the same as the current export certificate,” FDA said. “The export-only registration certificate is not specific to an exportation activity, but rather it serves as the product’s registration.” The agency said, “Exportation activities following the registration are part of the post-approval responsibilities,” the notification procedure supports monitoring export activities.

FDA received three comments on the suspension or cancellation of issued authorizations. The agency implemented one of the suggested changes. Originally, the draft said voluntary cancellation is possible if the action is not intended to “defraud the government, the authorization holder’s creditors, and/or its workers.” The revised guidance no longer mentions creditors or workers.

FDA Notice

MDA announces pilot survey for unique device identification in Malaysia

The Medical Device Authority (MDA) is running a pilot survey to inform the implementation of a unique device identification (UDI) system in Malaysia.

In the first phase of the pilot, MDA is surveying Class D medical device establishments. Class D covers medical devices with high individual and public health risks covered by the most stringent regulations. MDA will start the second phase of the pilot on 15 August, when it will begin a two-month survey of Class B establishments. Class B products have moderate individual risk or low public health risk.

“The purpose of this survey is to find out the readiness of the medical device establishments in Malaysia to provide all the information required regarding UDI for their registered products,” MDA said. “The results obtained from the survey will help the Authority to decide on the implementation timeline and new updates in our MeDC@St 3.0+.”

Currently, MDA plans to start the UDI transition phase in 2026. In the transition phase, UDI implementation will be voluntary for all classes of medical devices. MDA intends to make UDI mandatory for Class D devices in 2027. The system will become mandatory for all other classes of devices in 2028. MDA is aiming to have full UDI compliance in Malaysia in 2030.

The timeline could change based on the survey and assumes MDA’s new online application platform, MeDC@St 3.0+, is completed on time. MDA is aiming to have all platform modules online in 2027. The agency asked device companies to fully cooperate with the UDI survey to ensure reliable data collection.

MDA Notice

TGA fines telehealth businesses $216,000 for weight-loss drug advertising

Australia’s Therapeutic Goods Administration (TGA) has fined four businesses and three individuals AU$319,260 ($216,000) for allegedly unlawfully advertising prescription-only medicines on their websites.

Online telehealth clinics and medical practices offering telehealth services were among the organizations that received infringement notices. TGA alleges the businesses unlawfully promoted the use and supply of prescription-only medicines, including weight loss and erectile dysfunction medicines such as Ozempic, Saxenda, and Viagra. TGA also fined News Life Media for alleged unlawful medicinal cannabis advertising.

The regulator claims the telehealth companies advertised weight-loss medicines outside their approved indication, stating that certain prescription-only medicines were TGA-approved and that certain therapeutic goods were safe. Statements about the safety of therapeutic goods contravened the Therapeutic Goods Advertising Code.

“Advertising prescription-only medicines directly to consumers is prohibited under the Therapeutic Goods Act 1989 as it could create an inappropriate demand for these medicines and lead to unnecessary or harmful prescribing,” Nick Henderson of the Department of Health and Aged Care said. “Appropriate treatment options should be determined by a health professional in consultation with their patient.”

The actions come months after TGA fined InstantScripts AU$ 742,500 for alleged unlawful advertising of therapeutic goods. TGA accused InstantScripts of advertising prescription-only medicines in conjunction with the provision of telehealth services.

TGA Notice, More

Pakistan’s DRAP commits to ‘systematic implementation’ of bioequivalence

The Drug Regulatory Authority of Pakistan (DRAP) has committed to the “systematic implementation” of bioequivalence studies following international guidelines.

In 2018, DRAP adopted the common technical document for the registration of human drugs and established a process for submitting bioequivalence studies. Since then, the agency has continued to work to align its practices with international standards, including through benchmarking by the World Health Organization (WHO).

Benchmarking is part of a push to become a WHO Listed Authority. When deemed necessary to approve generic drugs, demonstration of bioequivalence and bioavailability is a prerequisite for obtaining maturity level 1.

At a recent meeting, DRAP’s board considered adopting the common technical document and the listed authority process and “decided the systematic implementation of bioequivalence study in accordance with the WHO and international guidelines.”

DRAP

Other news:

Alphapharm has resolved a shortage of Zactin Tabs (fluoxetine 20 mg dispersible tablets) in Australia. TGA listed a shortage of treatment for depression and other conditions in April and predicted the disruption could continue until mid-August. Zactin recently told TGA that supply has returned to normal. TGA Notice

Asia-Pacific Roundup: Philippine FDA responds to feedback on drug and API exports

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