Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Australian Generic Medicine Work-Sharing Trial Misses Completion Target
A work-sharing group involving Australian regulators has reported the results of its first collaborative assessment of a generic medicine. The review of the filing took about nine months, four months longer than the collaborators had targeted at the start of the project.
Officials from Australia’s Therapeutic Goods Administration (TGA) and their peers at the Canadian and Swiss drug regulatory agencies set out to shorten the review time by mimicking aspects of the decentralized process used in Europe. This posed a challenge given the differences between the agencies’ pre-acceptance processes, but TGA and its collaborators worked through these and other issues.
For the first filing, TGA served as the reference regulatory agency, with the Canadian and Swiss agencies assisting as concerned regulatory agencies. The applicant filed for approval in each of the territories. Work to identify differences in the dataset and requirements meant a complete filing was ready at the time of submission, although the applications had some differences. The data in modules two to five of the submission were the same, but there were differences in module one.
After reviewing the application, TGA and its collaborators put together a joint list of questions. This is one way the agencies think they can save time but on this occasion the process took longer than expected. The time the applicant got to respond was extended. Even so, an unanticipated second round of questions was needed.
That meant the first approval came in March, nine months after the application was filed and accepted. TGA and its partners were aiming to process the application in five months. Australian officials attributed the overshoot to the submission being more complicated than anticipated. Yet, despite missing the original target, the process still took less time than Canada and Switzerland's standard regulatory pathways.
The challenge now is to learn from the trial. TGA wants to widen the scope of the pathway beyond simple dosage forms, specifically solutions and immediate-release solid doses, to cover all types of generic medicine.
Future applicants will only be able to submit to two of the four agencies in the Australia-Canada-Singapore-Switzerland Consortium. Processing of these applications will take six to seven months or so, partly because of the inclusion of a second round of questions in the timeline.
CFDA Seeks Feedback on Regulation of Online Medicine Trade
The China Food and Drug Administration (CFDA) is seeking feedback on draft regulations covering the online trade in medicines. CFDA has drafted the document to clarify which organizations can trade online and what infrastructure and procedures they need to do so.
Under the draft rules, drug producers, wholesale enterprises and retail chains can sell drugs online. The rules prohibit wholesale enterprises from selling directly to individual consumers and require them, and the other types of organization, to meet certain requirements to trade with permitted customers.
The requirements proposed by CFDA include the establishment of a system that makes drug sales traceable and verifiable. CFDA also expects online traders to establish drug quality and safety systems, plus mechanisms for handling consumer complaints and reporting adverse events. Firms selling to individual consumers should have an online pharmacy service and licensed pharmacist to promote rational drug use.
CFDA provides some details about what these systems will look like in practice. In the case of the adverse event reporting system, the focus is on ensuring reports are forwarded promptly.
The regulation also covers how CFDA will keep tabs on and punish illegal activities. Organizations found to have breached the rules will face hefty penalties. CFDA plans to perform on-site inspections to enforce the rules.
CFDA is accepting feedback on the draft until 30 November.
CFDA Notice (Chinese)
India Introduces Tougher Regulations on Homeopathic Medicines
India has strengthened its regulation of the people and organizations who manufacture and sell homeopathic medicines. The legislation places new requirements on the qualifications of people who sell homeopathic therapies and applies pharmacopoeial standards to sites that make them.
Existing good manufacturing practices (GMPs) for homeopathic medicines make certain references to the use of pharmacopoeial standards but take a different approach in other areas. India is now eliminating some of these different approaches.
The new document removes the demand for raw materials to be “free of inorganic or organic foreign matter” and replaces it with the requirement for materials to comply with pharmacopoeial standards. Similarly, India is replacing an approach to quality control that allowed the verification of the purity of bark-derived materials using “a small twig of the plant with leaves” with a method tied to pharmacopoeial standards.
India is liberalizing other aspects of the GMPs, for example by dropping the requirement that dry materials are less than six months old when procured.
Legislators unveiled the changes in a notification that also covered the sale of homeopathic medicine. Again, these changes generally make India’s regulations more specific and rigorous.
The current text allows the sale of homeopathic medicines by anyone “who is in the opinion of the licensing authority competent” to do so. Under the incoming law, anyone wanting to “sell, stock or exhibit or offer for sale or distribute” homeopathic medicines will need a relevant degree or diploma.
Publication of the revised legislation follows a consultation that took place earlier this year.
TGA Starts Consultation on Premarket Evaluation of Herbal Component Names
TGA is seeking feedback on its plan to end premarket evaluation of the herbal component names (HCNs) manufacturers use to convey information to consumers. TGA currently approves HCNs, but is now questioning whether this is a good use of its resources.
HCNs are approved names of the components of parent herbal ingredients. Today, sponsors apply to TGA for clearance of HCNs, after which the agency reviews the submitted information. This entails looking at laboratory methods used in the analysis of the material and validation data.
TGA thinks the process provides a robust assessment of the application but that the value of an HCN is minimal as, once approved, other products can use the name without undergoing comparison to the original filing.
“This activity ... does not provide consumers with an assurance that HCNs are applied consistently across products,” the agency wrote in its consultation document.
Given that the process also “requires significant TGA resources, is not underpinned by legislation” and is not directly supported by industry fees, TGA is proposing to scrap the procedure.
This is one of two options TGA put to the industry in its consultation. The other option calls for the maintenance of the status quo, with the caveat that TGA may impose a fee on applications in the future. TGA wants to know which option people prefer and whether they have any concerns with ending premarket evaluation of HCNs.
If the industry supports scrapping the process, TGA will remove HCNs from the Ingredient Repository and archive forms and guidance related to the procedure. The agency will also consider developing a series of frequently asked question documents.
The National Pharmaceuticals Pricing Authority (NPPA) of India has quashed hopes it will lift price controls on coronary stents. NPPA is set to review the price cap early next year, but has stressed a reversal of its current price control course is not an option. However, it has not ruled out “objective rationalization.” NPPA Post