Asia-Pacific Roundup: TGA fines CMO for allegedly breaching terms of its production license

The Therapeutic Goods Administration (TGA) has fined the Australian pharmaceutical company Contract Manufacturing & Packaging Services (CMPS) AU$159,840 ($106,463) for allegedly breaching the terms of its license.
 
CMPS’ website states that it “manufactures pharmaceuticals under the strictest quality standards and complies with international manufacturing and health requirements of PIC/S countries.” Working out of a site in Sydney, the company makes complex formulations and dosage forms including tablets, capsules, soft gels and powders.
 
According to TGA, a recent inspection “identified unacceptable manufacturing practices.” The alleged breaches of the conditions of the manufacturing license include the retesting of products without taking the required steps to determine the root cause of failures. “Repeating testing, without identifying why the product failed, reduces confidence in the company’s ability to ensure their medicines comply with the specifications approved by the TGA,” the agency said.
 
TGA inspectors identified the issue as a “systemic problem which goes against globally accepted good manufacturing practices (GMP).” The alleged breaches of GMPs led TGA to issue 12 infringement notices that amounted to a fine of AU$159,840.
 
TGA has worked closely with the manufacturer of listed complementary medicines to “develop and implement effective preventative measures to address the GMP failures.” The agency said the “infringement notices are in response to past breaches and manufacturing can continue,” adding that “no disruption to the supply of their products is expected because of this action.”
 
One day after publishing a statement about the infringement notices, TGA revealed it fined another company, JSHealth Vitamins, AU$13,320 for alleged unlawful supply of a complementary medicine. The fine followed allegations that JSHealth supplied a complementary medicine that did not conform with the legal requirements. The medicine allegedly included an ingredient, Andrographis paniculata, that can cause loss of taste. The label lacked a warning statement to advise consumers about the risk.
 
TGA Notice, More
 
Malaysia updates guidance on classification of rehabilitation and physiotherapy devices
 
Malaysia’s Medical Device Authority (MDA) has updated its guidance on the classification of devices for rehabilitation, physiotherapy and speech therapy with a new annex and changes to existing sections. The document lists products that MDA classifies as medical devices.
 
MDA published the first version of the guidance less than one year ago and has now identified areas that need changing. The biggest change is the addition of a second annex that features examples of medical devices for rehabilitation, physiotherapy and speech therapy. In the new annex, MDA provides the names and photos of eight products that meet the definition of a medical device.
 
The technologies in the second annex are included in the existing list of products that meet the MDA medical device definition, meaning the main new information in the second annex are the pictures and photographs of the devices.
 
MDA also made changes to the original list of medical devices. Since publishing the first draft last year, the Malaysian regulatory agency has removed “examination lamp” from the list of products that are classed as medical devices. MDA has added “wrist and ankle weights, adjustable cuff weight” to the list, provided the devices are used for “progressive therapy or for rehabilitation of a specific injury,” rather than “general wellness purposes.”
 
The agency has also changed the information on the description, intended purpose and indication of some of the medical devices. MDA made significant changes to the section on finger weight exercisers, deleting the information that the devices are “uniquely designed to be worn during functional, everyday activities” and promote “speed and finesse in addition to strength.”
 
MDA Guidance
 
Pakistan’s DRAP encourages users to update pharmacovigilance app after recent revisions
 
The Drug Regulatory Authority of Pakistan (DRAP) has asked users of its Med Safety App to update the software to take advantage of new features and bug fixes implemented by the developer.
 
Members of the World Health Organization’s pharmacovigilance team worked with the UK Medicines and Healthcare products Regulatory Agency (MHRA) and Uppsala Monitoring Center to develop the app and get regulators in low- and middle-income countries to adopt it. By March 2021, 12 countries had received support for implementation.
 
Last week, DRAP published a notice about a “significant update” implemented by its counterpart in the UK. DRAP told users the MHRA update allows its National Pharmacovigilance Centre “to ask specific questions relating to a patient’s report based on the information provided.”
 
The revised app also “supports new features in the reporting form” and enables “requests for further information to be displayed within the app” and for user responses to be sent back to DRAP. Considering the extent of the changes, DRAP is encouraging users to update to the latest versions on the Android and Apple stores to enable it and other stakeholders to take advantage of the new features.
 
DRAP Notice
 
WHO terminates appointment of Regional Director for the Western Pacific over misconduct
 
The World Health Organization (WHO) has terminated the appointment of the Regional Director for the Western Pacific after investigating allegations of misconduct. Zsuzsanna Jakab will fill the vacancy on an acting basis until a permanent successor is elected in October.
 
WHO received allegations against the former director, Takeshi Kasai, in 2021 and 2022. The public health body investigated and reviewed the allegations in line with its “policy of zero tolerance for abusive conduct.” Kasai had the right to review all relevant evidence and respond to the allegations. At the end of the process, WHO delivered findings of misconduct and terminated the appointment.
 
The WHO statement lacks details of the allegations or investigation but media reports have provided more information. The Associated Press, which broke news of the allegations last year, reported that the investigation found the former Western Pacific regional director engaged in “aggressive communication, public humiliation, (and) making racial comments.”
 
Jakab has served as acting regional director since Kasai was put on leave last year. The Hungarian public health administrator will continue to lead operations in the region until an election can take place at a closed meeting of the Regional Committee in October.
 
Press Release
 
Malaysia’s NPRA creates declaration of worldwide registration status for generic medicines
 
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has created a template for declaring the worldwide registration status of generic medicines in its Quest online submission system.
 
The template asks users to provide information including the name of the product, its application status, and the application type and registration number in the registered country. If the application type is the decentralized procedure, NPRA wants the applicant to include the reference member state on the form. The template supports the provision of information about multiple products.
 
NPRA has designed the template for use with all new applications for prescription generic medicines. The creation of the template follows NPRA’s publication of a guide to uploading bioequivalence study reports to the Quest 3+ online portal and its updating of the guidance notes for active pharmaceutical ingredient information for product registration.
 
NPRA Notice
 
Other News:
 
TGA has seized more than 55,000 potentially dangerous products after an investigation into the alleged importation, advertising and supply of unapproved medicines. In executing the search warrants, TGA allegedly found unapproved prescription medicines for erectile dysfunction together with documents, packaging and advertising materials. TGA Notice