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Posted 24 May 2022 | By Nick Paul Taylor 

Asia-Pacific Roundup: Philippine FDA seeks feedback on abridged procedures for clinical trial applications

3036 The Philippine Food and Drug Administration (FDA) is planning to offer an abridged procedure for clinical trial applications by relying on other regulatory authorities. FDA is running a consultation about its draft guidelines on the proposal for regulatory reliance on the conduct of clinical trials in the Philippines.
 
It is now more than two years since FDA streamlined its clinical trial regulations. Having made the changes, FDA looked to the World Health Organization’s (WHO) principles and considerations on good reliance practices for pointers on how to further reform its approach, leading to the release of draft guidelines on how it plans to make better use of available resources and expertise. The WHO document encourages the use of work by foreign regulators to free up resources for essential national-level work.
 
“FDA ... recognizes that reliance will further streamline its review process and accelerate the conduct of clinical trials in the country. The existing regulations related to the conduct of clinical trials were streamlined to create a clear, simplified and transparent regulation, boost local competitiveness, and attract more local and foreign entrepreneurs,” the draft guidelines state.
 
The draft guidelines are intended to facilitate “evaluation of clinical trial applications addressing public health emergencies, rare diseases, cancer, HIV/AIDS, and emerging and re-emerging infectious diseases of public health threats.” In doing so, FDA aims to increase access to investigational medicines targeting those conditions.
 
Under the proposal, sponsors and contract research organizations planning studies of medicines in the aforementioned therapeutic areas can submit a copy of the clinical trial approval from a reference drug regulatory agency (RDRA) to support their application in the Philippines. The regulatory agencies of Australia, Canada, the European Union, Japan, the United Kingdom and the United States make up the initial list of RDRAs.
 
The abridged review process is designed to grant approvals to conduct clinical trials within 20 days. In that time, FDA will assess the completeness of the submission, review the materials, seek clarifications if needed and issue a decision. FDA retains the prerogative to assess the risks and benefits in the context of the situation in the Philippines, particularly when there “is a significant impact on the safety or physical or mental integrity of the subjects.”
 
When there are differences in the target population, epidemiology, concomitantly used medicines and other factors that can substantially affect the benefit-risk profile between the Philippines and countries regulated by the RDRAs, the applicant should provide appropriate justification in its submission. FDA may exempt a study from local good clinical practices inspections when an RDRA has run an inspection.
 
 
FDA is accepting feedback until 3 June.
 
Draft Guidelines
 
India adds section on suspending and canceling licenses to Medical Devices Rules
 
The Indian government has added a section on the suspension and cancellation of licenses to the Medical Devices Rules, 2017 to empower regulators to act when companies break the rules.
 
In the new section, the government describes what happens when, “The manufacturer or licensee fails to comply with any of the conditions of an import license, or any provisions of the Act and these rules.” If that happens, the central licensing authority will give the licensee a chance to set out why it should not pass an order against the organization for noncompliance.
 
Licensees that fail to successfully argue their case could face the cancellation or suspension of regulatory licenses. The suspension can last for as long as the central licensing authority sees fit and may apply “either wholly or in respect of any of the part of medical device.”
 
Affected licensees may have to stop the import, sale or distribution of their medical devices and destroy their stock in the presence of an officer authorized by the central licensing authority. The licensee can appeal the ruling to the central government within 30 days of receiving the order.
 
The final text is largely unchanged from the draft version released for consultation earlier this year.
 
Gazette Notification
 
TGA urges physicians to limit use of Ozempic to mitigate shortage created by off-label use
 
The Therapeutic Goods Administration (TGA) has joined with other Australian authorities to urge physicians to limit use of Novo Nordisk’s Ozempic to on-label applications to mitigate a supply shortage.
 
Semaglutide, the active ingredient in Ozempic, is approved in some countries for use in the treatment of obesity. In that context, the drug is sold as Wegovy. TGA is yet to approve Wegovy and the on-label use of Ozempic is limited to the treatment of adults with insufficiently controlled Type 2 diabetes mellitus as an adjunct to diet and exercise.
 
However, Australia has seen an “unexpected increase in consumer demand” because of “extensive prescribing for obesity management,” TGA said. The increase in demand has created a shortage that is “significantly affecting people using Ozempic for its approved use for Type 2 diabetes.”
 
With Novo Nordisk telling TGA there are sufficient supplies to cover the approved use, the company, agency and other Australian authorities have issued a joint statement asking healthcare professionals to only use Ozempic on-label to “prioritize essential continuity of care for people with Type 2 diabetes during the shortage.” TGA has authorized the use of Ozempic from overseas, but supplies may be limited.
 
TGA Notice
 
Pakistan's DRAP posts draft guidelines on categorizing GMP deficiencies for consultation
 
The Drug Regulatory Authority of Pakistan (DRAP) has published draft guidelines to inform industry of the principles inspectors use to classify good manufacturing practice (GMP) deficiencies.
 
DRAP created the document to facilitate the harmonized reporting of GMP deficiencies and ensure there is a consistent view across inspectorates of what constitutes a “major” or “critical” deficiency. The text is also intended to address the actions inspectors should take in response to major and critical deficiencies and to “promote increased consistency and predictability” through improved communication.
 
In the guidelines, DRAP provides definitions of critical, major and other deficiencies and a management tool to support their consistent and objective categorization. The tool consists of a series of flow charts that walk through the process for categorizing a deficiency.
 
Another section covers the actions inspectorates should take in response to deficiencies, explaining that the response should be detected by the categorization of the noncompliance, the history of the site, the potential risks and an assessment of the manufacturer’s proposed corrective actions. Inspectorates are to take immediate action if the findings relate to patient safety.
 
Draft Guidelines
 
TGA issues fines of $47,000 over alleged unlawful importation of ivermectin, doxycycline
 
TGA has fined an individual and a company AU$66,600 ($47,200) over allegations of unlawful imports. Both the cases involve the alleged importation of ivermectin, the antiparasitic drug that has been hailed in some quarters as a COVID-19 treatment despite a lack of evidence.
 
The individual received 15 infringement notices totaling AU$39,960 over allegations related to imports of ivermectin and the antibiotic doxycycline. Allegedly, the individual imported over 2,500 ivermectin tablets and nearly 10,000 doxycycline capsules in one month, far exceeding the quantity allowed under the Personal Importation Scheme.
 
Separately, TGA fined TMF Cosmeceuticals AU$26,640 for the alleged unlawful importation of ivermectin into Australia. The company is accused of twice importing ivermectin tablets that were not included in the Australian Register of Therapeutic Goods.
 
TGA Notice, More

 

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