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Regulatory Focus™ > News Articles > 2022 > 4 > Asia-Pacific Roundup: TGA cites two on pharmacovigilance compliance

Asia-Pacific Roundup: TGA cites two on pharmacovigilance compliance

Posted 12 April 2022 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA cites two on pharmacovigilance compliance

Australia’s Therapeutic Goods Administration (TGA) has issued infringement notices to two drugmakers over alleged breaches of the rules on pharmacovigilance. The two fines, each of which is for AU$13,320 ($9,890), relate to the alleged failure to provide information on a contact person responsible for medicine safety.
 
TGA frequently issues infringement notices, but they typically relate to breaches of advertising rules or importation of medicines. TGA hit Arthropharm with a fine last year but that is a rare example of an infringement notice stemming from the Pharmacovigilance Inspection Program, created after a pilot program in 2015-16.
 
Now, TGA has issued two pharmacovigilance fines in a day. Like the Arthropharm fine, the infringement notices to Ferngrove Pharmaceuticals and Kardwi Pharmaceuticals both relate to the alleged failure to list  a contact person responsible for medicine safety.
 
Under the Therapeutic Goods Act 1989, sponsors need to notify TGA of their pharmacovigilance contact person. TGA sees the requirement to notify it of the identity of the contact person as “an integral part of an effective and robust medicines safety system” that enables the detection, assessment and prevention of adverse events and other problems related to medicines.
 
Ferngrove Notice, Kardwi Notice
 
Philippine FDA seeks feedback on special certification of COVID diagnostic tests
 
The Philippine Food and Drug Administration (FDA) is running a consultation into the requirements for issuing special certification for in vitro diagnostic (IVD) medical devices used for detection and diagnosis of SARS-CoV-2 infection.
 
FDA issued the draft proposal as part of its work to ensure the quality, safety, accuracy and performance of COVID-19 IVDs. The proposal, which applies to manufacturers, traders and distributors, sets out the materials and information organizations must provide to receive the special certification they need to start manufacturing, importing, exporting or selling these tests.
 
FDA is requesting clinical studies and performance evaluations. FDA would prefer the studies and evaluations to be carried out by national regulatory authorities or independent parties such as the World Health Organization, Foundation for Innovative Diagnostics and accredited laboratories.
 
FDA also is requesting “a government issued certificate attesting to the status of the manufacturer with regard to the competence and reliability of the personnel and facilities, a Quality Systems Certificate of approval, or a compliance certificate for ISO 13485.” If the IVD is imported, FDA wants “an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the certificate is true and correct” and a certificate or product registration from a national agency or notified body.
 
FDA is accepting feedback on the draft until 8 May.
 
Draft Proposal
 
Malaysia’s MDA posts draft guidance on medical device change notifications
 
Malaysia’s Medical Device Authority (MDA) is seeking feedback on change notification guidance. The draft defines three categories of changes to registered medical devices and what they mean for affected companies.
 
MDA splits postmarket changes into three categories. Companies can implement category 3 changes immediately, although they still need to submit a request to MDA before taking action. The other two categories cover more substantive changes. Category 2 changes need MDA evaluation and endorsement prior to implementation. Category 1 changes require new registration because they affect the safety and performance of the medical device.
 
In two tables, MDA lists changes that fall into category 2 and category 3 and the documents needed  in relation to the planned actions. Changes to a manufacturing or sterilization facility fall into category 2 and require documents such as revised quality management system (QMS) certification, labels stating changes for each amended section and declarations that the processes are unchanged.
 
Examples of category 3 changes include revisions to the scope of the QMS, software changes which augment interfacing to non-medical peripherals, reduction or rephrasing of indications on the label, and updates to the name and address of the manufacturer. The turnaround time for category 2 changes is 30 days, compared to 15 days for category 3 changes.
 
The draft is open for comment until 20 April.
 
MDA Notice
 
Pakistan’s DRAP consults public about guidance on applying to run clinical trials
 
The Drug Regulatory Authority of Pakistan (DRAP) is running a consultation into clinical trial applications. DRAP has drafted the guidance to help sponsors, contract research organizations and other stakeholders that intend to file to run a clinical trial or make subsequent submissions.
 
In the draft, DRAP describes how to apply to run a clinical trial, explaining which forms need sending to where and the fees that need paying. DRAP wants applicants to bind their submissions in a single volume or a series of volumes with the pages numbered sequentially. The text should cross reference to copies of peer-reviewed publications the applicant provides separately to support the submission.
 
DRAP will screen submissions for completeness within 30 working days. Technical documents, such as materials related to nonclinical data and the study protocol, then undergo expert review. The expert comments are shared with the committee that is responsible for evaluating and approving the filing.
 
A section of the guidance covers non-routine procedures for applying to run clinical trials during a public health emergency. In such situations, the committee can fast track the processing of filings, eliminating the need for initial scrutiny by the Division of Pharmacy Services, and waive the requirement for auxiliary documents such as the sample label of the investigational product.
 
The draft, details of which were shared on 8 April, is open for comment for 15 days.
 
DRAP Notice
 
New Zealand’s Medsafe gets mixed feedback on proposed drug reclassifications
 
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has received mixed feedback on suggested changes to the classifications of certain medicines ahead of a meeting to discuss the proposals.
 
On 26 April, the Medicines Classification Committee will meet to discuss proposed changes to the classification of naloxone and modified-release nitrofurantoin. Neither proposal received the unanimous support of the organizations that submitted feedback on the planned changes.
 
The Pharmaceutical Society of New Zealand and the Pharmacy Guild of New Zealand voiced support for plans to allow modified-release nitrofurantoin to be supplied as a prescription medicine outside of certain circumstances, with the latter organization arguing the change is in line with international guidelines. However, the Royal New Zealand College of General Practitioners argued that allowing pharmacists to prescribe the medicine could contribute to antimicrobial resistance.
 
Respondents were also split on whether to down-schedule naloxone to improve access to the opioid overdose treatment. The Pharmaceutical Society supported the change, arguing that the current classification entails costs and work that are stopping companies from bringing products to market in New Zealand. The Pharmacy Guild opposed the change on the grounds that there need to be “appropriate advice mechanisms to ensure safe and equitable access to naloxone.”
 
Public Feedback
 
Other news:
 
TGA has provisionally approved Pfizer’s COVID-19 vaccine for use as a booster in children aged 12 to 15 years. TGA Notice

 

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