Asia Regulatory Roundup: Dengue Vaccine Nears Approval in India Without Local Phase III Data (19 January 2016)

Regulatory NewsRegulatory News | 19 January 2016 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Sanofi Secures Indian Committee Approval for Dengue Vaccine Without Local Phase III Data

An Indian drug regulatory committee has recommended allowing Sanofi to bring its Dengue vaccine to market without first generating Phase III data in a local trial. The committee thinks the divergence from normal protocol is acceptable given the scale of the health threat posed by the Dengue virus.

If the Drug Controller General of India (DCGI) accepts the recommendations of the Subject Expert Committee, Sanofi will be permitted to begin selling the Dengue vaccine in India on the strength of its existing dataset. Notably, while the dataset features Phase III results from trials run in Asian and Latin American countries including Thailand, Brazil and Mexico, it lacks information from late-phase studies about the effect of the vaccine in Indian citizens. Typically, locally generated late-phase data are needed to win approval unless certain conditions are met.

The Dengue vaccine fails to meet these conditions, but, with India emerging from its worst outbreak of the virus in years, the committee thinks it should be treated differently than other products. “[As] Dengue is a health problem of major concern in the country and can be life threatening in certain cases, the committee recommends for market authorization of the vaccine,” the committee wrote. The approval recommendation covers the use of the vaccine in people aged 18 to 45 years old. India would become the fourth country after Mexico, Philippines and Brazil to approve the vaccine.

For the approval to happen, DCGI must go along with the recommendation of the committee and Sanofi must agree to comply with certain post-marketing requirements. The committee wants Sanofi to submit a protocol for a Phase IV trial within three months of starting to market the vaccine. Such a transfer of the burden of data generation from pre- to post-approval is in keeping with the prevailing attitude at regulators around the world, which are increasingly comfortable with allowing drugs to come to market on the basis of a limited dataset and then keeping track of real-world outcomes.

Meeting Minutes, The Economic Times

CFDA Sets Timeline for Handling of Complaints

China Food and Drug Administration (CFDA) has set a timeline for the handling of complaints. The establishment of deadlines by which officials must act on complaints is part of a broader initiative to overhaul the procedures covering the handling of grievances and whistleblowing.

CFDA wants staffers to forward general complaints to the relevant departments within three days of receiving the feedback, after which a new set of deadlines becomes active. The regulator is aiming to wrap up investigations into most criticism within 60 days, although it is reserving the option to spend an additional 30 days looking into particularly complex cases. Officials seeking extensions to the typical timeline must make their request in writing and keep the complainant informed of the status of the investigation.

Setting the timeline is one of several ways in which CFDA is trying to fix shortcomings in the current system for dealing with whistleblowers and other complainants. When the revised procedure comes into force on 1 March, CFDA will implement a reward system and make other changes designed to encourage people to complain and simplify the process once they decide to do so. In the past, some complainants, notably Chinese anti-corruption official Lu Qun, have used social media to highlight concerns about CFDA, instead of going through established channels to bring up the issue.

Part of the challenge for CFDA is to persuade whistleblowers it will give critics a fair hearing. As such, CFDA is planning to take some high-profile actions, such as pushing CFDA staffers to publicize the complaints process and the regulations covering whistleblowers. Other planned changes, notably improvements to the information management system used to handle complaints, will be invisible to the public but are expected to contribute to the overall improvement of the process.

CFDA Notice, More (Chinese)

Japan Seeks Feedback on Plan to Harmonize Documents with US, Europe

Japan is seeking feedback on plans to harmonize certain documents with the pharmacopoeias of the US and Europe. The texts in question cover the use of instruments to measure the color of liquids and guidance on assessing the conductivity of solutions.

Officials at the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan and its peers in the US and Europe are considering adopting the documents as part of their combined push to harmonize texts. The documents, which are part of the agenda at the harmonization-focused Pharmacopoeial Discussion Group (PDG), have reached the stage in the process at which they are ready for release to the public. Each pharmacopoeia will then gather feedback and report back later in the year.

PMDA has given the industry until 15 March to comment on the texts. One of the documents, Q-07, is about using instruments to take consistent, objective measurements of the color of liquids. The text explains how researchers can take measurements that comply with pharmacopoeial requirements. PMDA is also seeking feedback on G-03, a text about the conductivity of solutions. The document sets out the recommended apparatus and calculations for measuring conductivity.

PMDA Statement (Japanese)

CFDA Crackdown on Substandard Drugs Rolls on with Actions Against 19 Firms

CFDA has taken another set of actions against companies suspected of manufacturing substandard drugs. The Chinese regulator, which closed out 2015 with a spate of actions, is now taking measures against 19 firms involved in the supply of drugs including the antibiotics isoniazid and cephalosporin.

Officials at CFDA singled out Sichuan Changzheng Pharmaceutical and Haikou Pharmaceutical, which work with isoniazid and cephalosporin, respectively, as the headline targets of the clampdown. The statement revealing the action against Sichuan Changzheng Pharmaceutical also featured details of alleged faults at 13 other companies, each of which will now see batches of its products recalled from the market. The five companies discussed in the second CFDA statement are also facing recalls.

CFDA has initiated the recalls after identifying a range of quality control failings, including the breach of microbial limits. The regulator is continuing to investigate some of the affected companies, which must take corrective actions if they are to resolve their issues with CFDA. In taking the actions, CFDA has continued the good manufacturing practice-focused agenda it followed last year into 2016. The regulator plans to conduct more routine and unannounced inspections this year than last.

CFDA Alert, More (Chinese)

Other News:

The Pharmaceuticals Export Council of India (Pharmexcil) has welcomed the relaxation of the rules covering the need for “no objection certificates” (NOC) when exporting drugs. Exporters can now send drugs to the US, Japan, Canada, Australia and the European Union without possessing a NOC. Indian regulators made the change following discussions with the Department of Commerce. Letter

Pakistan is planning to introduce a barcoding system for drugs. The Drug Regulatory Authority of Pakistan (DRAP) sees the introduction of an identification code system as a way to counter the rise of fake medicines in the country. Officials discussed the plan late last year and have shared details of their intentions with the industry. The specifics of the program are being finalized now. Daily Times 

CFDA approved 13 marketing applications last month. Drugs from domestic manufacturers accounted for most of the approvals. CFDA Notice (Chinese) 



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