Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Plans GCP Inspection Program to Ensure Global Recognition of Australian Data
Australia’s Therapeutic Goods Administration (TGA) is planning to run a good clinical practice (GCP) inspection pilot program. TGA sees the pilot as a stepping stone to a permanent, routine inspection program designed to mitigate the risk that recognition of the quality and integrity of clinical trial data generated in Australia will decline internationally.
Clinical trials run in Australia are assessed and green lit by the approving Human Research Ethics Committee (HREC), not TGA. While Australia thinks the model has speed, cost and access benefits, it also recognizes that depriving TGA of powers possessed by its global peers limits the agency’s ability to identify risks over the duration of a study. To compound matters, TGA lacks a routine inspection program to check whether clinical trials comply with GCPs.
Now, with the Australian government working to attract more clinical research to the country, TGA is set to address its lack of a routine GCP inspection program. The planned voluntary pilot program will inspect investigator sites testing medicines over a 12-month period to obtain feedback and develop systems that support an ongoing GCP inspection program.
GCP inspections are typically seen as a way to enforce compliance. That is one goal of the planned TGA program, too, but the Australian authorities also have a broader, more commercial objective.
“A domestic regulatory GCP inspections program will strengthen Australia as an attractive clinical trial research destination for both the local medical technologies, biotechnology and pharmaceuticals sector ... and in attracting internationally sponsored clinical trials.” TGA wrote. “It will address the potential risk of a decline in international recognition of Australian clinical trial data quality and integrity, and underpin creation of a highly productive commercialization environment.”
TGA has based the design of its proposed pilot program on the European Medicines Agency’s GCP inspections. During the inspections, TGA staff will review clinical trial data, informed consent procedures and other site activities related to GCP compliance.
Inspectors will categorize any deficiencies they identify during their visits as minor, major or critical and recommend remedial actions. TGA plans to share details of serious issues identified during GCP inspections with the HREC or authorizing institution. Compliance powers may be considered if the issues pose a risk to the safety of participants.
Despite that, TGA is framing the pilot program as a collaborative exercise, in part because it recognizes that many of the sites it visits will never have undergone a GCP inspection. TGA therefore wants to use the pilot to educate the sector while refining its processes. TGA will inform sites of the dates of its inspections and will hold open meetings to discuss its plan for each assessment.
If TGA receives positive feedback on the pilot, it plans to start the program in the coming months. Participants in the voluntary program will not pay a fee, with the funding instead coming from TGA’s general charges revenue. In the longer term, TGA notes that most comparable overseas agencies do not charge a fee for GCP inspections, but that expenses for its other services are recovered by fees and charges.
TGA is accepting feedback on the proposals until 22 February.
, TGA Notice
China Highlights Accelerated Reviews After Bumper Year for Device Registrations
China has highlighted the impact of its special review channel following a bumper year for medical device registrations. The National Medical Products Administration (NMPA) registered 21 devices via the channel last year, almost twice as many as in 2017, and shaved months off their review times.
The number of devices registered under the special review channel, which handles breakthrough medical technologies, rose slowly in the years following its introduction, growing from nine in 2015 to 12 in 2017. The rate of uptake changed in 2018 when NMPA registered 21 devices, increasing the number of products to come to market via the channel by more than 60% in a single year.
Chinese authorities created the special review channel to get breakthrough medical devices onto the market sooner. The characteristics of the devices registered via the channel and data on their review times suggests the initiative is working as intended.
According to the Center for Medical Device Evaluation (CMDE), products processed via the special channel were on average reviewed 83 days faster than other technologies that came to market for the first time. Devices that benefited from these accelerated reviews include vagus nerve stimulation implants and positron emission tomography imaging systems.
, CMDE Notice
India Proposes Reducing Staffing Requirements for Blood Processing Operations
India is planning to eliminate the need for blood collection, storage and processing operations to employ defined numbers of attendants and housekeeping staff. The revised staffing requirements are open for comment following discussions by the Drugs Technical Advisory Board (DTAB).
Currently, the rules imposed by the National Blood Transfusion Council (NBTC) require blood facilities to employ a minimum number of attendants and housekeeping staff based on the nature of their work and the size of their operation.
For example, facilities that collect and process up to 5,000 units of blood a year must employ one or more lab attendants or housekeeping employees. Facilities involved in the same activities that handle more than 50,000 units must employ at least eight attendants or housekeeping employees. Other staffing requirements apply to outdoor blood donation camps and blood separation facilities.
The staffing requirements released by the Central Drugs Standard Control Organization (CDSCO) for consultation lack the line stating how many attendants or housekeeping staff operations regulated by NBTC must be employed. Other aspects of the requirements, such as the number of medical personnel sites must employ, are unchanged from the current rules.
DTAB considered the changes at its 81st meeting and decided to seek public comment. CDSCO opened a 21-day comment period late last week.
TGA Discloses Additional Cases of Rare Lymphoma Linked to Breast Implants
TGA has confirmed four more cases of anaplastic large cell lymphoma (ALCL) in Australian patients. The update is part of the monitoring of patients who received Allergan's textured breast implants.
Australia’s TGA first commented on the link between breast implants and ALCL, a potentially fatal form of lymphoma, in 2011. TGA followed up by issuing advice from its expert advisory panel late in 2016, at which time it had received confirmed reports of 46 cases of breast implant-associated ALCL in Australia. Three of the cases resulted in death.
Since then, the number of Australian cases of ALCL associated with breast implants has continued to rise. The number now stands at 76, an increase of four cases since TGA last provided an update in 2018.
TGA maintained its current advice in the face of the increase and referred interested parties to a notice it published late last year after Allergan withdrew its textured implants and tissue expanders from the European market. At that time, TGA said it would talk to Allergan before deciding on what actions to take. TGA will update its position once more information is available.
The Indian Department of Pharmaceuticals
(DoP) has formed an inter-departmental committee to review and coordinate research. The committee, which is made up of representatives of DoP and other groups, is intended to ensure transparency in pharmaceutical research. DoP Memo