Asia-Pacific Roundup: CDSCO seeks feedback on biological postapproval change guidance

The Central Drugs Standard Control Organization (CDSCO) has released draft guidance on postapproval changes to biological products for consultation, proposing to add new sections on safety and efficacy changes.

Indian officials formed a committee in 2013 to update version 1.1 of the guidance on postapproval changes to biological products with an aim to “strengthen the processing of applications” and “update the quality information of already licensed products in a better systemic manner.”

Version 1.2 of the guidance has undergone significant changes. CDSCO is proposing to add a new category of quality changes, level IV, that marketing authorization holders can implement without prior regulatory review. Level IV changes are not expected to adversely affect the identity, strength, quality, purity or potency of the drug product. Examples of level IV changes, such as replacement of filter housing and changes to the color of stopper caps, are listed in an appendix.

CDSCO is also planning to add information on the supporting data for level IV changes and a new section on the classification of safety and efficacy changes. The draft guidance advises marketing authorization holders to put changes related to clinical use and product labeling into one of four categories based on the likely impact on safety and efficacy.

The agency defines level I changes as any revision to the label of a drug “that has the potential to change the exposure levels of the drug, either by expanding the population that is exposed (i.e. related to market expansion), or by increasing individual exposure.” Examples of changes that may increase exposure levels include the addition or expansion of a safety or efficacy claim.

At the other end of the scale, changes that are not expected to affect safety or efficacy can be made without prior review by CDSCO and communicated in annual notifications. Changes to labels that “add clarity and maintain consistency with common label phrase standards” can be made without first being reviewed by CDSCO.

Other proposed updates to the guidance include the addition of sections on administrative product labeling information changes, comparative studies and quality by design. CDSCO is accepting feedback on the draft for 45 days. The agency said it prepared the draft in consultation with stakeholders and in alignment with documents from other regulators and the World Health Organization.

CDSCO Notice

TGA seeks to ban GLP-1 compounding to mitigate safety risks

Australia’s Therapeutic Goods Administration (TGA) has launched a consultation on its plan to immediately ban the compounding of GLP-1 receptor agonist analogs in light of “public health and safety concerns.”

Compounding pharmacies have stepped in to increase the availability of GLP-1 drugs as demand for the approved products semaglutide and tirzepatide has outstripped supply. Semaglutide and tirzepatide, which are respectively sold by Novo Nordisk as Ozempic and Eli Lilly as Mounjaro, are authorized by TGA in type 2 diabetes but are being prescribed off label to manage weight loss.

Last year, the US Food and Drug Administration (FDA) warned consumers about compounded semaglutide, noting that it has received adverse event reports and information that compounders may be using salt forms of the active ingredient. TGA followed up with a notice about the risks of compounded GLP-1 drugs.

TGA now proposes to remove GLP-1 receptor agonist analogs from the pharmacist extemporaneous compounding exemption. Removing the molecules from the exemption will prohibit the compounding of the medicines by pharmacists.

“Public health and safety concerns have emerged around the complexity and commercial scale of some compounding of extemporaneously prepared GLP-1 Ras,” according to TGA. The risks include the unknown nature and safety of the ingredients, “compounding outside of the current exemptions that specify manufacture only on an individual patient basis and only after receipt of a valid prescription” and the absence of safety and quality evaluations, TGA said.

TGA has launched “a targeted consultation process” on “immediate changes” to the rules on compounded GLP-1 drugs. State and territory chief health officers and chief pharmacists and the Australian Health Practitioner Regulation Agency have already unanimously said “that current regulatory arrangements regarding compounded medicines should be strengthened to provide improved public protection,” according to TGA.

The agency, which previously removed the compounding exemption from medicinal cannabis, is now giving “identified stakeholders” a chance to comment on its plans. TGA aims to make a final decision by June.

TGA Notice

Singapore gathers views on planned changes to rules on disclosing patents in filings

Singapore’s Health Sciences Authority (HSA) is inviting feedback on proposed changes to patent declarations in registration applications.

Regulation 23 of the Health Products (Therapeutic Products) Regulations requires HSA to consider whether a patent is in force when it is assessing registration applications. The applicant must provide a patent declaration and tell the patent proprietor if a submission affects their intellectual property. The mechanism is intended to quickly resolve potential patent disputes.

HSA is considering changing the regulation to clarify that applicants must disclose patents related to the active ingredient, the formulation or composition of the therapeutic product, and “ the use of an active ingredient in the manufacture of that therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use.” Other patents are outside of the scope of the disclosure requirement.

The changes are intended to “ensure a system that facilitates all industry stakeholders in making registration applications and minimize any potential indiscriminate use of the mechanism,” HSA said. The agency is accepting feedback until 31 March.

HSA Notice, More

TGA publishes draft framework for managing breast implant risk for consultation

TGA has begun a consultation into a draft breast implant risk management framework. The framework sets out processes to identify and manage risks associated with the medical devices.

The long-term implantable devices are linked to risks including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). TGA is taking a “proactive approach” to monitoring the risks to ensure issues are identified and mitigated quickly. The draft framework describes TGA’s approach to risk identification, communication and management.

TGA’s proposed approach to risk identification is built on postmarket surveillance, including adverse event reporting and post-market reviews, and gathering intelligence from registries and the healthcare sector. The Australian Breast Device Registry collects, analyzes and publishes data on breast device procedures.

Other sections of the framework describe how TGA communicates risk information, including by advising the sponsor or manufacturer of the “appropriate procedures to undertake to correct their problem,” and discusses the tools the agency uses to manage risk. TGA lists “appropriate regulatory requirements for new breast implant models” and clinical evidence guidelines among the ways that it manages risk.

The agency is accepting feedback on the draft until 26 March.

Draft Framework

Other news:

The Drug Regulatory Authority of Pakistan (DRAP) is seeking feedback on draft guidelines for risk-based sampling and testing of drugs. The guidelines “reflect a structured approach on regulatory oversight by allocating resources efficiently by prioritizing sampling collection, testing and surveillance based on risk levels,” DRAP said. The goal is to focus regulatory efforts on high-risk areas. DRAP Notice

Asia-Pacific Roundup: CDSCO seeks feedback on biological postapproval change guidance

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