Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India Prepares for Joint National-State Inspections of Manufacturing Plants
India has laid the groundwork for joint inspections of drug manufacturing plants by officials from national and state regulatory agencies. Officials will conduct joint inspections whenever a facility seeks a license to make or sell drugs and at risk-determined intervals to check ongoing compliance.
The joint inspections should help to harmonize quality standards across India and stop disconnects between state and national agencies, as happened with the approvals of fixed-dose combinations. If the joint inspection model is to achieve these goals, state licensing authorities and the offices of the Central Drugs Standard Control Organization (CDSCO) will need to collaborate effectively. Much of the preparatory work performed to date reflects this fact.
Writing this week In a notice to state agencies and regional CDSCO offices, the Drug Controller General of India (DCGI) set out a workflow for the new model. Companies seeking to manufacture drugs will submit whichever of Form 25, 28 and their variants is applicable to their product to the local state licensing authority. The state body will then coordinate with zonal and subzonal offices of CDSCO to set a date for the inspection. The date should be set at least one week before the visit.
DCGI Dr. GN Singh acknowledges the potential for the process to break down at this stage and has put contingency measures in place. If the the zonal or subzonal CDSCO office is unable to make an inspector available on the chosen date, the headquarters of the national regulator will send one of its employees.
Singh expects all three layers of the regulatory machinery to work closely on the licensing process.
“Proper coordination between the state licensing authorities, CDSCO HQ and zonal/subzonal offices should be ensured for timely inspection and processing of the application,” Singh wrote.
The need for cooperation will be particularly acute if the inspectors identify deficiencies. In this case, Singh expects the joint team to “verify such documents during the inspection and record details of the same in the inspection report.”
India is moving to the joint-inspection model as part of a broader set of changes to how agencies award and renew licenses. Provided the drug manufacturing or testing operation stays compliant and deposits the license renewal fee before their clearance expires, the certification will remain valid indefinitely. Officials will assess continued compliance in joint inspections held “not less than once in three years or as needed per risk-based approach.”
CFDA Maps out Strategy to Promote Regulatory Transparency
The China Food and Drug Administration (CFDA) has set out how it will interpret and implement the government’s call for greater transparency. CFDA’s roadmap discusses the transparency of the regulatory decision-making process, open data and the shaping of messages in old and new media.
CFDA, building on the central government’s openness agenda, has committed to listening more to public opinion when making decisions and doing a better job of explaining how it reaches policy positions. Once CFDA reaches a position, it plans to keep the public well informed about its implementation. The goal of these and other aspects of the transparency agenda is to improve the credibility of the government.
Interpretation and communication is another plank of CFDA’s work toward this goal. When making policies and regulations in specialized fields of interest to the general public, CFDA will spend more time interpreting its actions for a lay audience. This will entail the publication of press releases, policy briefings and other documents that contextualize and explain the news in a simple manner.
CFDA will accelerate this process when faced with emergencies. In these scenarios, CFDA plans to make a statement within five hours and hold a press conference within 24 hours. The fast response is intended to stop CFDA from losing control of the narrative, as happened to an extent when news of the vaccine storage scandal broke last year.
In both routine and emergency situations, CFDA will use state-owned media publications and privately owned social media platforms such as WeChat to get its messages to the public. The agency also wants its leaders to be the experts media organizations turn to for interviews when reporting on drug-related stories.
CFDA Statement (Chinese)
CDSCO Again Calls for Experts to Join its Regulatory Committees
India has put out another call for experts to join the panels and committees that advise the DGCI. CDSCO made a similar request last year, around the time a lack of experts forced it to cancel a string of planned meetings.
CDSCO is casting its net even wider this time. The list of panels for which the agency is recruiting covers 43 therapeutic areas and modalities, plus the catchall term “other related areas.” That is up on the 29 panels CDSCO recruited for in May 2016.
The list includes panels covering analgesics, dermatology, rheumatology, endocrinology, neurology and psychiatry. CDSCO has called off meetings focused on all of these areas over the past two years owing to a shortage in experts.
Regulatory officials need access to the experts to guide evaluations of data submitted to support applications for drug and clinical trial approvals, as well as for the creation of guidance documents.
The terms offered to experts are the same as last year. CDSCO will pay experts Rs 2,500 ($39) for each meeting they attend. The fee has risen considerably since 2012 — when it stood at Rs 1,000 — but has now plateaued. Experts are expected to commit to holding office for three years and provide feedback on proposals within six weeks, even if they are unable to attend the associated meeting.
CFDA Creates Roadmap for Medical Device Clinical Trial Transition Period
CFDA has disclosed the timeline for the phased introduction of changes to medical device clinical trials. The new rules officially come into force on 1 January, but CFDA will allow sponsors of device trials to continue choosing study sites under the existing regulations until the end of 2018.
That makes 1 January 2019 the key date for sponsors. After that, CFDA expects sponsors to choose clinical trial institutions from among those registered with its filing system. The system will record details of clinical trial institutions eligible to test medical devices in humans.
CFDA is implementing the changes as part of a far-reaching drive to raise the standard of medical device testing and manufacturing in China. As such, the agency is backing up the filing system with a renewed focus on monitoring clinical trial sites. CFDA wants organizations to file annual summaries of their trial activities and expects its units to step up their inspections of study sites.
CFDA Notice (Chinese)
The Therapeutic Goods Administration (TGA) of Australia has revoked the suspension of a Philips’ wearable patient monitor. TGA suspended the license in May after learning of an uptick of failures in the speakers the device uses to sound the alarm in critical situations. Philips has since recalled and replaced the IntelliVue MX40 devices, leading to the lifting of the suspension. TGA NoticeApotex
has expanded the recall of Apo-Perindopril Arginine
in Australia. TGA first alerted people to the recall earlier this month, at which time three batches of the cardiovascular disease medicine were affected. Apotex added another eight batches to the recall in the following days. The firm added another four batches to the recall list this week. TGA Notice