Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Reveals Recently Passed Order Faced Strong Industry Opposition
Australia’s Therapeutic Goods Administration (TGA) has revealed that parts of the medicines industry objected strongly to its recently adopted standard for tablets and capsules. The legislation came into effect in March despite big pharma trade group Medicines Australia arguing that, “It is unclear what value the order provides.”
TGA sought feedback on the minimum quality standards for medicine tablets or capsules late last year in anticipation of the sunsetting of the prior order at the start of April. The agency framed the revisions to the outgoing document as a way to cut regulatory burdens and increase harmonization, most notably by permitting manufacturers to follow the European or US Pharmacopoeias, not just their British counterpart. Despite that goal, parts of the industry criticized the order.
“It is unclear what value the order provides in further defining standards for prescription medicine tablets and capsules,” Medicines Australia wrote in its feedback. “It is highly unlikely that sponsors of new medicines will find the order a useful reference point for defining 'standards' for tablet or capsule formulations including setting specification limits for impurities or heavy metals.”
Medicines Australia’s questioning of the value of the order rests on the fact that TGA has adopted all relevant International Conference on Harmonisation (ICH) and Committee for Medicinal Products for Human Use (CHMP) guidance about the quality of capsule and tablet dosage forms. The trade group thinks TGA’s adoption of ICH and CHMP guidance is particularly relevant for medicines that contain new molecular entities.
Manufacturers of these medicines typically use the principles set out in ICH guidelines to develop tests and acceptance criteria, enabling them to compensate for the lack of an existing monograph. That led Medicines Australia to conclude that the TGA order is unlikely to be of use to the industry.
Medicines Australia generally voiced support for specific aspects of the order, noting that its focus on the harmonization of standards is a “positive.” However, as the trade group sees it, that positive is more than offset by the downsides of legislation that “duplicates requirements included in existing default standards.” In the absence of anything new, Medicines Australia argued the order “offers little value and adds regulatory burden for both evaluators and sponsors.”
TGA did not refer to Medicines Australia’s overarching criticism of the order in its summary of the 24 responses to the call for feedback, opting instead to focus on some of the specific points made in the submissions. These specific points led to changes to the draft ahead of the order coming into effect earlier in the year.
Peptide Clinics Fined AU$10M in Early Victory for TGA’s Advertising Team
The Australian Federal Court has ordered Peptide Clinics to pay AU$10 million ($7 million) for breaching medicine advertising rules. The ruling gives TGA a victory in one of the first cases taken up by the government after the regulator took charge of the advertising complaint process.
TGA took over the advertising complaint handling system in July 2018. In November, the Australian Department of Health began proceedings against Peptide Clinics, arguing that promotional materials on its website “encouraged the use of” certain prescription-only medicines for purposes including anti-aging, bodybuilding, fat loss, injury repair and heart health.
Peptide Clinics made changes to its website shortly after the legal case began, but the government continued its pursuit of the company. The case carried on even after Peptide Clinics went into liquidation, culminating in last week’s ruling by judge Jayne Jagot.
“I accept the Secretary's submission that ‘Peptide Clinics has deliberately and recklessly pursued its own financial self-interest at the expense of its legal obligations and the interests of public health,’” Jagot wrote. “The business model of Peptide Clinics depended on contravening the statutory provisions.”
With Peptide Clinics in liquidation, there was no need for the punishment handed down by Jagot to deter the company from breaching the rules in the future. However, the government called for the court to impose a sizable penalty to make it clear “that companies will not be able to profit from their wrongdoing.” Jagot concurred, resulting in a penalty in the middle of the range proposed by the government.
, Court Judgment
India Forms Medical Device Technical Advisory Group to Help CDSCO
The Indian government has formed the Medical Devices Technical Advisory Group (MDTAG). The group will advise the Central Drugs Standard Control Organization (CDSCO) on the regulation of medical devices.
With India now 18 months on from the enactment of the Medical Device Rules, a large part of the work performed by MDTAG will relate to the implementation of the requirements. MDTAG will also propose ways that CDSCO can strengthen medical device regulations. The notice disclosing the creation of MDTAG singled out ease of doing business and the Made in India agenda as focal points.
Drug Controller General of India (DCGI) Eswara Reddy will chair the 22-member advisory group. The members include representatives of a notified body, state-level regulatory agencies, national bodies such as the Bureau of Indian Standards and medical device and diagnostic trade groups. MDTAG will also feature four doctors who work at health centers in India.
The committee has the option to bring in other experts as required to help with specific activities. DCGI Reddy will call the committee to meet at CDSCO’s headquarters at least every four months.
NPPA yet to Recoup 86% of Money Overcharged by Drugmakers in India
India’s National Pharmaceutical Pricing Authority (NPPA) has revealed it has recouped just a fraction of the money drugmakers have overcharged consumers over the past 22 years.
NPPA has struggled for years to get companies that overcharge for medicines to pay back the excess. The agency has tried for more than a decade to improve the process, including by empowering local government authorities to collect fines, but the latest figures show the pipeline of payment remains clogged.
Writing in response to a question in parliament, the Indian Minister of Chemicals and Fertilizers said NPPA has recouped 14% of the Rs. 6370.20 crore ($926 million) it has demanded from drugmakers over its 22-year history. Almost three-quarters of the outstanding payments are tied up in litigation.
The information was submitted to parliament on the same day as a response to another question involving NPPA. The second response provided details of 22 medicines that came to market without prior approval of NPPA. Boehringer Ingelheim and Sanofi are among the listed drugmakers.
NPPA has demanded Rs. 101 crore from the companies but, in keeping with the prevailing situation, is yet to receive the vast majority of the money. Around 5% of the money has been repaid. Most of the outstanding money requested by NPPA is under litigation.
has warned consumers not to rely on breast thermography to detect breast cancer. The method, also known as thermal breast imaging, uses an infrared camera to measure temperature differences in the belief that cancerous areas will be warmer. However, TGA thinks there is too little evidence to support the use of the technique in the early detection of breast cancer. TGA Notice
The Phillipine Food and Drug Administration
(FDA) has issued a notice about the availability of an unregistered B Braun device, Introcan. FDA Notice