Asia-Pacific Roundup: Philippine FDA improves operating license process for drug, device companies

The Philippine Food and Drug Administration (FDA) has published an administrative order to update the license-to-operate (LTO) rules, requirements and procedures for drug and medical device companies.

Companies that make, import, export, sell and otherwise handle medicines, medical devices and other health products must secure a LTO from FDA. FDA revised its guidelines on issuing, renewing and changing LTOs in 2020 to adopt a more harmonized licensing system across all health product establishments.

Now, the agency is repealing the order it published in 2020 and establishing new rules, requirements and procedures. FDA said it needs to update the list of technical and documentary requirements. Companies need to comply with the requirements for FDA’s evaluation of technical compliance and the inspection of covered establishments to ensure the safety of their health products.

FDA is extending the validity of LTOs as part of the update. The 2020 order said FDA would state the duration of the validity of LTOs in other documents. FDA’s website says initial and renewed LTOs last for 2 years and 5 years, respectively. The latest order extends the validity of initial and renewed LTOs to 6 years for medium-sized enterprises and 12 years for large enterprises. Micro and small enterprises get 3 years for initial LTOs and 6 years for renewed licenses.

The agency also framed the guidance as part of its work to address “emerging concerns,” stay abreast of internationally accepted standards and strengthen its regulatory capacity and licensing, inspection and monitoring capabilities. FDA aims to integrate information and communication technology to “maximize a focus on risks, promoting faster coordination and information sharing.”

FDA Notice

TGA seeks feedback on changes to online presentation of Australian guidance documents

Australia’s Therapeutic Goods Administration (TGA) has updated how it presents guidance on its website and is seeking feedback for additional potential updates.

TGA revealed plans to update its guidance website in August. The agency made the changes in response to feedback that said its documents are difficult to find and navigate.

In response, TGA has collated documents that explain “the laws and regulations governing the development, manufacturing, marketing and supply of therapeutic goods in Australia” in a new guidance section. Users can filter the listings by audience, product type, topic or the year the text was last updated.

Within each document, TGA has added a navigation bar to the top of each page to allow users to jump between sections and provided a detailed table of contents. Readers can bookmark and share specific sections. Other changes include tags to show a document that has recently been updated, page history sections to show what has changed and links to clearly show the relevant legislation.

TGA now wants to know if users have noticed the changes and if they make it easier to find documents and identify new and updated materials. TGA is also asking if users agree that the changes make it easier to understand what they need to do, share documents and navigate to specific sections of texts.

TGA Notice

HSA works with Amazon, Facebook and others to pull illegal online listings in Singapore

Singapore’s Health Sciences Authority (HSA) has worked with e-commerce and social media platforms to remove 3,336 illegal health product listings.

HSA worked with Amazon Singapore, Carousell, Ebay Singapore, Facebook, Lazada, Qoo10, Shopee and Tiktok to remove the listings. The agency said the action was “a first-of-its-kind large-scale collaboration with online platform administrators.” The cooperation led HSA to send 1,471 warnings to sellers and to investigate a repeat offender for the sale of illegal health products.

The joint operation targeted the sale and supply of illegal products such as substandard and counterfeit goods. Almost half of the withdrawn listings covered aesthetic enhancement products such as botulinum toxin, the active ingredient in Botox. Antibiotic, antifungal or antiviral products accounted for 10% of the listings. Around 40% of the listings advertised prescription or pharmacy-only drugs.

Annie Tan, director of enforcement branch, health products regulation group at HSA, called the operation a “significant milestone” in the agency’s ongoing efforts to disrupt the online sale and supply of illegal health products. HSA plans to continue working with online platforms to proactively remove illegal health product listings.

Press Release

Anticipated product shortages prompt proactive effort from TGA

TGA has published notices about anticipated shortages of drugs from Janssen-Cilag and Pfizer Australia to help prepare for the disruption.

Pfizer told TGA it expects a shortage of its antibiotic Bicillin L-A to last from 20 December to 10 January. The anticipated shortage affects the 1.2-million-unit prefilled syringe product. An existing shortage of the 600,000-unit prefilled syringe product is expected to continue until April. TGA has approved an overseas registered product to mitigate the anticipated shortage of the 1.2-million-unit syringes.

TGA shared details of the Bicillin L-A shortages, which are caused by manufacturing issues, days before providing information on the supply of the attention deficit hyperactivity disorder (ADHD) drug Concerta. Johnson & Johnnson’s Janssen-Cilag told TGA it expects shortages of two more doses of the drug to start on 19 December. Shortages of two different doses began in October.

Janssen-Cilag expects the shortages to last until the end of May. The other supplier of modified-release methylphenidate hydrochloride tablets, Teva Pharma Australia, expects to resolve the shortage of some of its products in mid-December. TGA is urging affected patients to talk to their pharmacists about supply and consult with their prescribers about their treatment plan.

TGA Notice, More

TGA adopts temporary labelling exemptions to ease transition to new paracetamol rules

TGA has established temporary exemptions to the labeling requirements for paracetamol to minimize the potential for disruption when new rules take effect on 1 February.

The incoming changes will reduce the maximum pack sizes sold in various settings to reduce the harm from intentional overdose. As part of the update, some companies need to change the “signal words” for certain pharmacy and pharmacist-only medicines.

TGA published two temporary labeling exemptions in relation to the changes. One exemption gives companies 12 months to adopt the new requirements on signal words. That exemption starts when the rules take effect in February and runs through January 2026.

The other exemption allows pharmacies to supply newly labelled “Pharmacist Only” products before the revised rules take effect on 1 February. Such products do not comply with the outgoing requirements but are permitted for sale under the exemption.

TGA Notice

Asia-Pacific Roundup: Philippine FDA improves operating license process for drug, device companies

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