Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news.
Australia Excludes Certain Cells, Tissues and Organs From Some Regulatory Oversight
The Therapeutic Goods Administration (TGA) of Australia has exempted some types of cell, tissue and organ from its regulatory framework. TGA’s actions affect certain autologous human cell and tissue (HCT) products, solid organs and other materials that could be classed as biologicals.
Acting on legislation signed into law last month, TGA has excluded four types of material from its definition of therapeutic goods and the rules that status entails. Broadly speaking, TGA granted the materials the exempted status on the grounds that they undergo little, if any, processing before being administered to patients.
That line between processed and unprocessed materials is evident in TGA’s explanation of when it classes autologous HCT products as biologicals. TGA classes most autologous HCT products as biologicals. The exceptions are blood components that only undergo “minimal manipulation.” These products fall under the definition of blood component, exempting them from the requirements TGA places on biologicals.
In other cases, TGA will exclude autologous HCT products from all its regulatory requirements. TGA will only grant that regulation-free status if the HCTs are collected, processed and administered in a hospital either by or under the supervision of the same medical or dental practitioner. TGA will not grant the exemption to products that are advertised to consumers. Bone grafts and vascular conduits are among the types of product that may benefit from this total regulatory exemption.
TGA has also created another status for some autologous HCT products that are used outside hospitals. The criteria for this status overlap with those of the in-hospital designation but only grant exemption from some rules, such as good manufacturing practices (GMPs). Requirements related to adverse event reporting and other matters still apply to the products used outside hospitals.
The agency devoted less energy to explaining the exemption criteria for the other three types of materials. These exemptions have simpler criteria for qualification than the rules on autologous HCT products. For example, TGA is continuing to exclude solid organs used in direct, donor-to-host transplantation from its definition of therapeutic goods. The other exclusions affect haematopoietic progenitor cells for direct donor-to-host transplantation and reproductive tissue.
TGA brought the exemptions into force at the start of July but has put arrangements in place to ease the transition to the new regime. The transitional arrangements exempt certain autologous HCT products from aspects of GMP requirements and other regulations.
Pakistan Adopts Rules on Conduct of Clinical Trials
Pakistan has adopted rules covering the authorization and conduct of clinical trials. The rules require organizations involved in the running of clinical trials to obtain a license and meet certain standards.
The Drug Regulatory Authority of Pakistan (DRAP) is targeting the document, called the Bio-study Rules, 2017, at contract research organizations, clinical research laboratories, bioavailability and bioequivalence study centers and other public and private groups involved in testing medicines in humans. All these groups must apply to the clinical studies committee (CSC) for a license to perform their functions.
Applicants must provide a non-refundable fee and evidence that they meet certain standards. DRAP is limiting licenses to organizations with sites that are “free from offensive and obnoxious odours and other possible sources of contamination” and have “adequate” space, facilities and equipment. The organizations should also have at least one employee with a medical science degree and “sufficient” clinical support staff. Organizations that meet these and other requirements set out in the rules will receive a three-year license.
A separate application, plus accompanying fee, is required for each clinical trial. DRAP will appoint experts to review each application. Working through DRAP, the reviewers may query the applicant and ask to see preclinical data before sending a report to the CSC. The CSC will decide whether to approve or reject the application at its next meeting. In some cases, the CSC will process filings on a fast-track basis. Clinical trials must secure ethical clearance, too.
DRAP’s rules also detail requirements for the conduct of clinical trials. The CSC expects to receive a report of the results obtained in a clinical trial every quarter and the final dataset when the study is finished. All adverse events must be reported immediately to DRAP. The CSC can terminate a trial if the sponsor and investigators fail to meet these and other requirements. To ensure sites are following the rules and the study protocol, the CSC will perform random inspections.
The rules came into force on the day they were published last month.
TGA Introduces Online Advertising Complaint Form Ahead of Code Changeover
TGA has created an online form to collect consumer complaints about advertisements for drugs and medical devices. The form is designed to make it easier for consumers to send complaints to the TGA, which has taken sole charge of non-compliant advertisements as part of broader changes affecting the field.
To support its expanded role, TGA has introduced an advertising hub that houses the form and other tools. The form is aimed at consumers who have seen an ad they think is non-compliant with the legislation. TGA wants consumers to provide detailed information about their concerns, although it does not expect them to identify the section of the legislation they think has been breached. People can also submit complaints by phone or email.
The agency has created various resources to help consumers, including fact sheets on the complaint handling process, what to look out for in ads and how to make a complaint. TGA has also created a video about reporting ads.
These resources are part of a broader library of information housed on the hub. Other sections of the repository cover sanctions and penalties, guidance for advertisers, education and training and recent TGA decisions.
TGA launched the hub alongside news of the switchover to the 2018 advertising code. The code is now finalized but will not come into force until the start of next year. TGA is holding off on adopting the new code to give companies time to bring their ads in line with the revised requirements. To support these efforts, TGA is providing training and education to advertisers.
India Raises Maximum Age of New Hires at CDSCO
India has raised the maximum age of new hires at the Central Drugs Standard Control Organization (CDSCO). The agency has reset the cutoff point at over 58 years of age, two years above its previous level.
The change at CDSCO is part of a broader shift at the Indian government. A cutoff point of 56 years of age was standard for jobs in all ministries and agencies, but in recent months job ads have begun to list 58 as the maximum age. That age is now enshrined in CDSCO’s recruitment rules.
The two-year increase in the maximum age is roughly in line with improvements in life expectancy in India since the previous recruitment rules came into force in 2011
The New Zealand Medicines and Medical Devices Safety Authority
(Medsafe) has moved to a new fee schedule. Medsafe switched to the revised fee structure at the start of the month, but will allow companies to defer paying the additional charges until January. Medsafe Notice