Asia-Pacific Roundup: Philippine FDA seeks feedback on import and export notifications

The Philippine Food and Drug Administration is running a consultation into draft guidelines on import and export notifications for pharmaceutical products and raw materials.

FDA stopped issuing letters of clearance or certifications to release imported pharmaceutical products and raw materials in 2013. Since then, companies have needed to present a valid license to operate (LTO) and a certificate of product registration (CPR). LTOs and CPRs remain part of the agency’s vision for the future of pharma imports but FDA sees a need to increase oversight of the supply chain.

“There is a need to strengthen market control within the distribution chain through measures to ensure that the public only receives quality-assured pharmaceutical products. The infiltration of substandard and counterfeit pharmaceutical products into the supply system shall be prevented through risk-based surveillance schemes and rigorous control,” FDA said.

Under the draft guidelines, manufacturers, contract research organizations and other groups involved in the supply of raw materials and pharmaceutical products would need to submit a notification for “every shipment and all batches,” FDA said. Notifications would be filed 1-30 days before the shipment is scheduled to arrive or depart the Philippines.

Required documents would be submitted via the eServices portal and acknowledgements of successful submissions would be submitted via email. The Bureau of Customs (BOC) would release import and export shipments without asking to see the notification acknowledgement. FDA would inspect BOC and third-party warehouses to ensure compliance with good practices and other requirements.

The inspections would be part of a broader program of regulatory oversight. The guidelines aim to “establish and identify the authorized ports of entry and exit of pharmaceutical products and raw materials into and out of the country for effective border control.” An annex names nine authorized ports with secure storage facilities, plus cold storage areas.

FDA would enforce the requirements through risk-based postmarketing surveillance activities on the arrival or departure of shipments including collecting pharmaceutical product samples for testing and collaborating with BOC and law enforcement agencies. BOC would coordinate with FDA to seize all unauthorized shipments.

FDA is accepting feedback on the draft until 20 May.

FDA Notice and Draft Guidelines

DRAP calls out failures to comply with post-registration variation guidelines

Pharmaceutical companies are failing to submit applications for variations of registered drugs as required by updated guidelines implemented by the Drug Regulatory Authority of Pakistan (DRAP) in October 2023.

The guidelines feature a form for submitting post-registration variation applications as an appendix. Using the form, pharma companies can provide information about their business, the product being updated and the nature of the requested variation. Companies must submit the form alongside other documents and a fee.

Last week, DRAP wrote to pharma manufacturers, importers, and industry groups to report companies' failure to comply with the requirement. “It has been observed that variation applications are not being submitted on the prescribed ‘Form’ and as per documentation requirement provided against each variation,” the agency wrote.

The issue prompted DRAP to ask pharma trade groups to advise their members about the requirements and procedures set out in the updated guidelines on post-registration. Variation filings that are submitted without a “filled Form and incomplete documentation shall not be entertained in future,” DRAP said.

DRAP Notice

Japan’s PMDA discusses risk management plans in clinical settings

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has outlined the use of risk management plans (RMPs) in clinical settings in its monthly safety information report.

RMPs describe the safety specifications, pharmacovigilance activities and risk minimization activities for each active ingredient. Within the safety specifications, RMPs cover important identified risks, important potential risks and important missing information. PMDA discussed the significance of the plans in the April edition of its Pharmaceuticals and Medical Devices Safety Information report.

“It is important to utilize the risk management plan ... to ensure proper use of drugs and minimize risks. RMPs are prepared to sort out, from the phase of development onward, the risks of drugs (information on adverse drug reactions, etc.) to be collected after marketing and to examine and implement activities to minimize the risks and collect information,” PMDA said.

RMPs explain how to collect information and minimize risks related to each potential harm associated with an active ingredient. The activities are a mix of routine actions performed for all medicines and steps specific to the risks posed by a particular active ingredient. A recent change to dispensing fees means pharmaceutical management based on RMPs at pharmacies is now included for evaluation.

PMDA Report

TGA aligns nitrosamine limits with EU
Australia’s Therapeutic Goods Administration (TGA) has updated its list of acceptable intake limits for nitrosamine impurities in response to changes made by the European Medicines Agency (EMA).

TGA has based its approach to setting acceptable levels of nitrosamine impurities on the activities of its counterpart in the European Union. With EMA updating its information, TGA has added intake limits for 14 impurities and revised the restrictions on one existing product.

EMA’s update included an increase to the acceptable limit for an impurity in dabigatran etexilate, an anticoagulant medicine used to prevent strokes and treat deep vein thrombosis. Previously, the intake limit was 400 ng per day. EMA reset the limit at 1,500 ng per day “based on negative bacterial reverse mutation test.”

TGA took the same action last week, increasing the limit for dabigatran etexilat while introducing its first restrictions on the levels of 14 other impurities. The agency added limits for products including the schizophrenia therapy clozapine, breast cancer drug tamoxifen, herpes treatment valacyclovir and the intravenous antibiotic meropenem.

TGA Notice

India updates committee on reform of drug and device pricing framework

India’s Department of Pharmaceuticals (DoP) has updated its committee for reforming the drug and medical device pricing framework in response to feedback from industry associations.

DoP formed the committee last month. At that time, there were three core members, two from DoP and one from the National Pharmaceutical Pricing Authority (NPPA), and two special invitees from industry. DoP asked the committee to consider how to reform NPPA, balance essential medicine price and availability while incentivizing industry, and create a device price moderation framework.

Since then, industry associations left off the committee have contacted DoP to ask to take part in the process. The requests led DoP to add 12 special invitees to the committee.

As well as increasing the number of Indian bodies involved in the committee, the expansion has given groups with an interest in the US a say in the process. AdvaMed, an American medical device trade association, now has a representative among the special invitees, as do the US-India Strategic Partnership Forum and the U.S.-India Business Council.

DoP Notice

Other news:

The Philippine FDA has formed a task force to consider how to streamline the classification of borderline health products. FDA has created the group because “the development of an increased variety of health products” has resulted in goods that “share similar characteristics or are considered ‘borderline’ between the different product categories.” FDA Notice

Asia-Pacific Roundup: Philippine FDA seeks feedback on import and export notifications

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