Asia Regulatory Roundup: Australia to Adopt 10 EMA Guidelines (4 October 2016)

Regulatory NewsRegulatory News | 04 October 2016 |  By 

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

Australia Starts Consultation on Planned Adoption of 10 EMA Guidelines

The Therapeutic Goods Administration (TGA) of Australia is seeking feedback on its plan to adopt 10 European Medicines Agency (EMA) guidelines. Most of the documents are replacements for existing EMA texts previously adopted by TGA, but some, such as guidelines on clinical development of drugs against Duchenne muscular dystrophy (DMD), would be entirely new additions.

EMA’s DMD guideline is one of eight texts up for adoption by TGA that address clinical development. The DMD guideline, which took 30 months to go from the start of the consultation to the agreement on a final draft, is one of the more high-profile texts in a set of guidance documents that also cover clinical trials in amyotrophic lateral sclerosis, asthma and other indications. Apart from the DMD text, all of the clinical trial guidelines TGA is considering adopting are replacements for earlier documents from EMA.

The other wholly new guideline covers the use of pharmacogenomic methodologies when carrying out pharmacovigilance evaluations. That guideline came into force in the EU on 1 April — making it the oldest of the documents set for adoption by TGA — to provide the industry with an overview of how genomic biomarkers that influence how a person responds to a drug can factor into pharmacovigilance activities and product labeling. TGA thinks the correlation between summaries of product characteristics and its own product information means it will be possible to adopt the text.

Officials at TGA are similarly confident the other texts will translate to its regulatory environment. The only issue mentioned by TGA relates to one section of an appendix to EMA guidance on the evaluation of anticancer candidates in humans. In the section, EMA discusses the use of pathological complete response as endpoint in neoadjuvant breast cancer trials. TGA plans to adopt the section, but only “following implementation of a provisional registration process by the TGA.” The addition of new approval pathways was the subject a recent government report in Australia.

TGA is accepting comments on its plan to adopt the EMA guidelines until 9 November.

TGA Notice

TGA Rethink Means Shorter, Less Frequent Inspections for Well-Regarded Manufacturers

TGA has revised its inspection schedule to reduce the frequency and comprehensiveness of its visits to manufacturers with a history of high-level compliance. The changes affect companies that receive A1 inspection ratings, a group that TGA, after taking into account its experiences in recent decades, thinks can be monitored less while still producing safe, high-quality products.

Officials have created matrixes to show manufacturers of different types of products how frequently and thoroughly they can expect to be inspected. The sliding scale means manufacturers of low-risk drugs with excellent compliance records will receive fewer inspections than companies that produce high-risk therapeutics and have fared poorly when visited by regulators in the past. Companies with a track record of poor compliance will undergo longer inspections, too.

For example, a company that manufacturers high-risk products, such as sterile medicines and cellular therapies, will receive a visit 12 months after receiving the low A3 rating from inspectors. In contrast, a company that makes the same products but receives an A1 rating will go 24 months between visits. TGA is also rewarding consistent inspection successes. A second consecutive A1 rating extends the period between TGA inspections to 36 months, while a third makes a company eligible for a reduced scope inspection.    

The same model applies to manufacturers of low- and medium-risk products, but, as the products they make are less likely to cause harm, TGA is visiting them less frequently than high-risk companies with comparable inspection records. TGA is putting manufacturers of low-risk products on 36-month inspection cycles after they achieve one A1 inspection. 

A similar model is in place for producers of medical devices, although the details differ because TGA wants to fit at least two surveillance inspections in between the conformity assessments companies must undergo every five years. No manufacturer will go more than 20 months between inspections and, in contrast to the rewards for consecutive successes offered by TGA to drug producers, only the last inspection is taken into account for medical device companies.

TGA released the revised inspection timetables alongside an update to its risk framework. The new framework features an “other” category for manufacturers of homeopathic products and non-sterile active pharmaceutical ingredients. TGA will only inspect companies in the “other” category when it has information that suggests a visit is needed. 

TGA Notice

Shortage of Essential Medicine Prompts CDSCO to Call Manufacturers to a Meeting

The Deputy Drugs Controller of India (DDCI) has called five manufacturers to a meeting after learning a drug has “disappeared from the market.” Penicillamine, the drug in question, is a chelating agent that is on the World Health Organization’s Model List of Essential Medicines.

DDCI R Chandrashekar contacted German Remedies, Panacea Biotec, Samarth Lifesciences, VHB Lifesciences and Chandra Bhagat Pharma last week and told them to attend a meeting. The purpose of the meeting was to discuss the supply of penicillamine, an important drug in the treatment of Wilson’s disease. While penicillamine used to be available in India, supplies have become limited, according to Chandrashekar.

The regulator wanted to use the meeting to figure out how to get the drug back on the market. Yet, if reports in the Indian media are accurate, the situation that led to the shortage is complicated. One of the manufacturers, Panacea Biotec, pins the blame on a sudden disruption of supplies from a vendor. The company wants the Central Drugs Standard Control Organization (CDSCO) to allow it to import raw materials in parallel and go through the registration process to alleviate the situation.   

Other observers think the situation is more complex than that described by Panacea Biotec. “Once it came under price control, the drug’s prices have become low and suppliers from countries like China have not been supplying to India,” an anonymous source told The Economic Times. “Even the limited suppliers from India have begun to prefer exporting the raw material to get a better margin.”

DCGI Letter, The Economic Times, Business Standard

CFDA Proposes Revised Classification of Medical Devices

China Food and Drug Administration (CFDA) is proposing to revise how it classifies medical devices. The changes to the 14-year-old way of working are intended to bring the classification system in line with the emergence of new types of medical devices and address some of its fundamental flaws,

Proposed changes to the system include the addition of information beyond the name and category of the product. Specifically, CFDA plans to add descriptions of products and their intended uses. The regulator is also aiming to make the classification system more capable of incorporating novel types of medical device and iron out some of the technical shortcomings of the current directory.  

CFDA detailed its revised classification system and the thinking behind its changes in an extensive document and accompanying annexes. CFDA has given the industry until 25 November to comment on the draft classification system.

CFDA Alert

Other News:

TGA has removed four extended-release metformin products from its list of drug shortages. The resumption of supply of two types of Diabex XR and Diaformin XR reverses the steady worsening of the situation that has characterized the past few months. TGA Alert 



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