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Regulatory News | 08 November 2016 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China's Food and Drug Administration (CFDA) has verified data generated in clinical trials sponsored by AstraZeneca, Johnson & Johnson and Sanofi among the first batch of 55 clinical trials to be verified by the regulator under its data audit initiative.
The list of drugmakers to go through the data verification process to date is skewed toward foreign companies. Astellas, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Merck and Takeda join the three aforementioned large pharmaceutical companies on the list. The predominance of firms based outside China reflects the initial focus on applications to import drugs into the country. All of the overseas' drugmakers filings were classed by CFDA as relating to imports.
CFDA has also processed six filings for generics, one for a new drug and another for a supplementary application. These submissions all came from Chinese companies and, given that they mostly relate to generics, are the sort of filings targeted by CFDA when it set out to identify substandard applications in its fast-expanding backlog. That initiative started out by asking companies to self-audit their data, a process that led some applicants to voluntarily withdraw their submissions. That done, CFDA is now into the next stage of the process.
The 55 verified applications are the start of CFDA's push to confirm the quality of filings, force the withdrawal of those that fall short of its standards and punish any organization found to have acted fraudulently. As of the end of September, CFDA had sent out 73 verification teams to perform these tasks. While the scale of the verification operation is dwarfed by the backlog prior to the start of the self-audit initiative, CFDA is claiming the overall campaign has slowed the pace of new applications and caused the industry to adopt more cautious, rational regulatory strategies.
CFDA Notice, More (both Chinese)
The Therapeutic Goods Administration (TGA) of Australia has shared feedback on its draft clinical evidence guidelines for medical devices. Johnson & Johnson and Medtronic are among the 24 organizations to comment on the draft.
TGA published the draft guidelines in March to gauge industry responses to planned changes to its stance on the generation of clinical evidence to support the registration and ongoing use of medical devices. The draft, like many of TGA's recent proposals, sought to align processes in Australia with international practices. Documents created by the Global Harmonization Task Force, now replaced by the International Medical Device Regulators Forum, and the European Commission MEDDEVs were particular touchstones for the text.
The harmonization agenda attracted the support of organizations including J&J, although several respondents put forward concerns and possible improvements to the approach. J&J, for example, wants TGA to delay imposing any unique requirements through the clinical evidence guidelines until the commission has finalized the fourth revision of its MEDDEV guidance on the same topic. Similarly, Medtronic wants clarification of when TGA's guidance differs from MEDDEV. The request is underpinned by experience of TGA finding fault with filings that supported registrations in Europe.
Overall, TGA found respondents want it to clarify the roles and responsibilities of sponsors, clinical experts and other groups. Respondents also questioned the scope of the document, when it is appropriate to do randomized clinical trials and the structure of the proposed Clinical Evaluation Report.
CFDA has started consultations on changing the dosage forms and other properties of generic drugs. The draft guidance documents fit into a broader initiative to ensure the safety, quality and efficacy of generic medicines through conformity assessments.
One of the texts set out the factors CFDA will assess before registering a generic that uses a salt form of the active pharmaceutical ingredient (API) approved in the innovator product. Generic medicine developers use salt forms to improve the stability and other physical and chemical properties of a drug without affecting its biological activity. The European Medicines Agency allows the use of salt forms "as long as it does not affect the medicine's activity."
CFDA has now detailed its own take on the salts, which some observers think affect the equivalence of generics to reference products. To allay such concerns, CFDA wants manufacturers to present the rationale for the change and data to back up its scientific validity. Data from studies of the physicochemical properties of both formulations, assessments of the toxicology of the salt form and other tests are among the results requested by CFDA.
The second document takes a similar approach to the evidence needed to support modifications to oral solid dosage forms. Again, CFDA wants applicants to the discuss the rationale for their changes and present data to support their modifications. The regulator expects applicants to perform stability tests, impurity analyses, bioequivalence trials and other studies to generate data to back up their filings.
CFDA is accepting feedback on both texts until 1 December.
CFDA Notice, More (Chinese)
China Food and Drug Administration (CFDA) has shared a notice about good clinical practices (GCPs) for trials of medical foods. The document seeks to standardize processes in trials of the emerging class of products while also protecting the rights and safety of study subjects.
Many of the requirements detailed in the guidance will be familiar to anyone who has run clinical trials in China or elsewhere. CFDA expects principal investigators, statisticians, data managers, nurses and physicians specialized in the disease under investigation to be involved in clinical trials of medical foods. Many of the tasks involved are similar, too. Clinical trial protocols, informed consent requests and case report forms all apply to trials of medical foods. An ethics committee needs to sign off on these documents and processes before the trial begins.
While these and other aspects of the GCPs overlap with the requirements for drug and device trials, the text is tailored to medical foods in both minor and major ways. The list of people who need to be involved in the study, for example, includes a dietitian. Good manufacturing practices (GMP) apply to medical food trials as they do to more traditional therapeutics, but the details of what is needed to demonstrate quality differs. The design of the trial itself and the endpoints will also differ from drug trials.
Despite these differences, the overarching message of the text is that companies must approach trials of medical foods with the same level of scientific and regulatory rigor as drug studies. This attitude is in keeping with the registration process CFDA adopted for foods for special medical purposes earlier this year. That text established the need for the clinical trial guidance by stating any product intended to be the sole source of nutrition for a patient must undergo clinical trials before it can be approved for use in China.
CFDA has adopted the approaches to the registration and development of medical foods in response to growing interest in using nutrition to manage a range of conditions affecting its population. Diabetes, kidney disease, chronic obstructive pulmonary disease, cancer and other conditions are all potential targets for medical foods.
Tags: Asia Regulatory Roundup, Regulatory Roundup