Asia Regulatory Roundup: India Adopts Risk-Based Approach to Biologic Licenses (20 December 2016)

Posted 20 December 2016 By Nick Paul Taylor

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

India Adopts Risk-Based Approach to Biologic Licenses, Ending Mandatory Inspections

The Drug Controller General of India (DCGI) has scrapped the need for manufacturers to undergo a joint inspection before receiving certain biologics licenses. Instead of conducting pre-approval visits, Indian regulators will award Form 29 licenses within three days of receiving applications and follow up with risk-based inspections later.

Form 29 licenses clear companies to manufacture vaccines and recombinant DNA products for the purpose of examination, test or analysis. Historically, manufacturers wishing to gain such clearance submitted an application and underwent joint inspection prior to receiving the necessary license. However, with Indian regulators seeking to make the country a better place to do business, DCGI Dr. GN Singh has removed this potential barrier.

Now, instead of running pre-approval inspections, the Central Drugs Standard Control Organization (CDSCO) will issue licenses to all Form 29 applicants within three days. This will allow manufacturers to start producing vaccines and recombinant DNA products for testing almost as soon as they have suitable operations and the supporting paperwork in place.

Manufacturers with Form 29 licenses may still face joint inspections, but these will be performed on a risk-assessed basis after CDSCO has cleared them to produce biologics for testing. The move from a comprehensive, upfront inspection program to a risk-based model is in keeping with broader shifts in regulatory policy in India.

In May, CDSCO published details of a new risk-based approach to the inspection of manufacturing facilities. As of last month, CDSCO had inspected 76 facilities under the new model and was planning to start reassessing sites to gauge their responses to feedback in January.

The risk-based approach may also reshape how licenses to make, sell and test drugs are handled in India. DCGI Singh has proposed making such licenses permanent, ending the need for companies to undergo periodic renewals, but the exact details are still taking shape. The initial proposal called for license holders to undergo re-inspection at least every 10 years, but the Drugs Technical Advisory Board has proposed a risk-based model that uses annual assessments as its baseline.

DCGI Memo

TGA Details International Engagement Strategy for Next Five Years

The Therapeutic Goods Administration (TGA) of Australia has published its international engagement strategy through 2020. Many of the priorities are continuations of existing goals, but TGA is also planning new initiatives affecting pre-market assessment and post-approval monitoring of drugs and medical devices.

Australia stepped up its interest in international engagement through the 2013-15 strategy, notably by committing to participating in collaborations and relying on reports from overseas regulators to support its decisions. Since then, a review of the regulatory landscape in Australia has reiterated the importance of international engagement. The latest strategy document reflects the reform agenda that grew out of the review.

TGA has retained many of the broad objectives from the earlier strategy document, but has tweaked its specific goals in response to progress to date and the reform agenda. New objectives include the development of a more comprehensive drug and device post-market monitoring scheme. TGA wants the scheme to support “enhanced collaboration” and the exchange of information about the safety, quality and efficacy of drugs between regulators. The exchange of information that supports market authorization decisions is another possibility.

The regulator has also set its sights on making pre-market assessment and authorization processes for drugs and devices more flexible. TGA is particularly keen to address processes used to recognize existing quality management system assessments from established commercial third parties and its regulatory peers.

Changes to post-market monitoring and pre-market assessment both fall under the broad goal of “working with others to improve the regulatory system.” Many of the other new initiatives are classed as “participating in work sharing, information sharing and regulatory convergence activities.”

Specific TGA goals in this category include a move toward approving drugs and devices for use in Australia on the basis of evaluations run wholly or partly by overseas regulators. “This will reduce duplication of effort, leading to efficiencies, while maintaining protection for Australian consumers through oversight by the TGA as the final decision-making authority,” the agency wrote in its strategy document.

TGA Strategy

DCGI Tells State Regulators to Push Pharmacies Into Cashless Economy

DCGI Singh has told state regulators to help India transition away from cash payments and toward digital transactions. The regulatory leader wants regional officials to tell pharmacies to adopt digital payment methods to support the phasing out of cash.

Singh set out his position on digital payments at pharmacies in two letters. One letter went out to all state drug controllers. In that letter, Singh outlined CDSCO’s work to move away from cash payments and the perceived legal and economic benefits of cashless societies, before going on to detail the changes pharmacies need to make and the role regional regulators can play.

As pharmacies typically make lots of low-value transactions, Singh sees them as ideal candidates to facilitate the shift from cash to digital payments. As such, Singh wants state drug controllers to “advise all pharmacy shops, druggists, chemists and businesses, all other players in the supply chain in your jurisdiction to switch over to use of digital technology in their day to day.”

Singh sent a similar letter to pharmacy trade groups. That letter asked the industry bodies to advise all their members to switch over to use of digital payment technology in their day-to-day operations.

Neither letter details whether pharmacies that fail to comply with the request will be punished, but a lot is resting on them and organizations in other sectors heeding the advice. Last month, Indian Prime Minister Narendra Modi abolished the 500- and 1,000-rupee notes, which at the current exchange rate are worth approximately $7 and $15. Modi framed the action as part of the anticorruption campaign that helped him win election in 2014.

However, in the near term, abolishing notes that account for 80% of currency in India has caused problems for consumers and traders. One potential consequence is India, a country unusually reliant on cash, may start making more payments by card and other digital methods. For this to happen, pharmacies and other traders need to accept digital payments, something the letters sent by Singh this week seek to encourage.

DCGI Letter, More

China Posts Draft Guidance on Biologics Batch Release

China Food and Drug Administration (CFDA) has released draft guidance on the batch release of biologics. The draft text updates a document that came into force in China in 2004.

CFDA has used the update to try to strengthen and standardize practices in a key step in the process of manufacturing vaccines, blood products and other biologics. The draft defines the term batch release and sets out which agencies will be responsible for certain tasks, such as sampling, on-site inspections and development of technical requirements.

Changes to the current text include the addition of a section on the role of drug testing institutions, greater focus on the re-inspection process and the linking of punishments to those enabled by other regulatory texts.

Draft Guidance (Chinese)

Other News:

The Indian Pharmacopoeia Commission has issued a notice about a nationwide skill development program. IPC Notice

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Categories: Biologics and biotechnology, Medical Devices, Regulatory strategy, Regulatory intelligence, News, Asia, CFDA, CDSCO, TGA

Tags: Asia Regulatory Roundup, India biologic licenses, cashless economy

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