Asia-Pacific Roundup: Philippine FDA seeks feedback on plans to automate License to Operate application system

The Philippine Food and Drug Administration (FDA) has released draft guidelines on how manufacturers, clinical research organizations and other businesses can apply for a License to Operate (LTO).

Three years ago, FDA published revised guidelines designed to simplify the requirements and processes for initial, renewal and variation LTO applications. The administration has now identified a need to make more changes, specifically to “further re-engineer the FDA’s processes and automate its system” and “update the list of documentary requirements for LTO applications.”

The proposed changes proposed extensive and cover topics beyond the automation of the system and revision of the documentary requirements. In a section on general guidelines, FDA has added text to state that licensed establishments are responsible for the safety, efficacy, quality and purity of products sold in original, untampered packaging and must comply with applicable standards including good practices. FDA now plans to add tamper-proof security to its LTO certificates.

FDA has proposed major changes to the section on specific guidelines, starting with new text on the conditions that different types of licensed organizations such as drug and medical device establishments must comply with. The new text clarifies that organizations that 3D print medical devices must apply for an LTO.

The new subsection on the activities of qualified personnel (QP) explains that all establishments should have at least one QP who must ensure compliance with FDA procedural, documentary and technical requirements. The QP is responsible for telling FDA about any changes to the submitted materials to ensure continuous compliance.

The draft also covers new information on the application process, payments and inspections. The application section now states that misrepresentation of the information in an application will be “subject to administrative and criminal liabilities,” and that “automatic LTO issuance shall only take effect provided the applicant’s requirements are compliant with the conditions of automatic renewal.”

FDA has expanded and completely rewritten the section on inspections. The section explains when FDA will inspect facilities, outlines the documents that companies need to have “readily available at all times” and discusses the administration’s authority to enter any establishment engaged in regulated activities. Initial LTOs will be valid for five years and renewals will last for 10 years.

The draft is open for comment until 30 June.

Draft Guidelines

India publishes changes to drug pricing legislation, moves to update multiple forms

The Indian government has published amendments to its drug licensing legislation, tweaking multiple forms that drugmakers use to submit information as well as the pricing and availability of their products. The changes come about through the latest set of changes to the Drugs (Prices Control) Order, 2013.

Officials included multiple forms in the original order to support applications for price fixation, revised prices, the discontinuation of production and other planned commercial changes to medicines sold in India. A notification published in The Gazette of India last week sets out changes to clarify aspects of four of the forms.

The revised form for price fixation clarifies that the applicant should provide “the retail price claimed for approval (in rupees per unit, excluding taxes).” The government has also clarified which parts of the form on revising prices should include and exclude taxes. That form now features a column on the rate at which the Goods and Services Tax is applied to the product.

Officials are making similar tax-related changes to the form used to apply to discontinue products. That form also now features a section on pack size that was missing from earlier versions of the document.

The government is making the most extensive changes to “Form – V Proforma for Price List.” As well as the tax changes made to other forms, officials are adding new columns to gather information on the pre-revised maximum retail price, the batch number and date from which the price revision is effective, and the production capacity.

Gazette Notification

TGA backs MHRA plan to use Australian authorizations to inform rulings on UK approvals

Australia’s Therapeutic Goods Administration (TGA) “is committed to [supporting] the new international recognition framework” that its counterpart in the UK is introducing for medicines.

Last week, the UK Medicines and Healthcare products Regulatory Agency (MHRA) firmed up plans to use the decisions of a small group of international partners, including TGA, to inform its own rulings on the approvals of new medicines. MHRA framed the initiative, which is scheduled to start in the first quarter, as a way to save companies money and accelerate access (RELATED: Euro Roundup: MHRA outlines plans to recognize drug approvals from 7 global regulators, Regulatory Focus, 01 June 2023).

In the statement, TGA said that the international recognition routes have been facilitated through MHRA’s involvement in the Access Consortium and Project Orbis and are part of a new UK framework for medicines following its exit from the European Union.

TGA discussed its regulatory reliance activities, explaining that it “currently has several application pathways in place for sponsors to submit applications, including the Comparable Overseas Regulator (COR) pathway.” COR, which has been in place for several years, allows TGA to make use of the assessments of regulatory agencies including MHRA.

TGA Notice

Indian experts reject Abbott’s ‘inadequate’ request for local antibiotic clinical trial waiver

An Indian subject expert committee (SEC) has rejected Abbott Healthcare’s request to waive the need to run a local clinical trial for an extended-release formulation of the antibiotic clarithromycin.

Last week, Abbott presented at a meeting of the Central Drugs Standard Control Organisation’s (CDSCO) antimicrobial and antiviral SEC. According to the SEC, Abbott used its presentation to seek permission to manufacture and market Clarithromycin ER Tablets 1000mg, “along with the report for local clinical trial waiver before the committee.”

The CDSCO committee was unconvinced by the proposal, observing that the “justification presented by the firm is inadequate.” After assessing the proposal, the committee recommended that Abbott run a Phase 3 clinical trial and a bioequivalence study. Abbott will need to submit a protocol for the Phase 3 trial for further review if it goes ahead with the requested study.

SEC Recommendations

TGA adds serious kidney damage to list of risks associated with oral anticoagulants

TGA has updated the product information for oral anticoagulants to warn that the products can cause serious kidney damage in rare circumstances.

The agency added the warning, which applies to Bayer’s Xarelto, Boehringer Ingelheim’s Pradaxa and Bristol-Myers Squibb and Pfizer’s Eliquis, after reviewing reports of anticoagulant-related nephropathy in patients taking such medicines. TGA called the adverse event rare but serious, adding that it can cause irreversible kidney damage and death and is likely underdiagnosed as a cause of acute kidney injury.

TGA wants to increase awareness of the side effect because early detection and treatment “is critical to reducing permanent kidney damage and death.” The products now carry a special warning that discusses the risk and explains that it applies to “patients with altered glomerular integrity or with a history of kidney disease.”

TGA Notice, More

Asia-Pacific Roundup: Philippine FDA seeks feedback on plans to automate License to Operate application system

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