Asia Regulatory Roundup: TGA Shares Guidance, Tool to Help Companies Navigate GMP Clearance Process (26 September 2017)

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

The Therapeutic Goods Administration (TGA) of Australia has released guidance and a web-based tool to help companies file good manufacturing practice (GMP) clearance applications. TGA created the resources to further its attempt to improve the application process and prevent the issues that contributed to the lengthening of processing times.

In moving from the 17th to 18th versions of its GMP clearance guidance TGA has radically revised the text. The new version runs to 61 pages, more than 50% than were in the previous iteration. TGA has used the additional pages to expand on everything from the basics — answers to the questions "What is GMP clearance?" and "Why is it needed?" are among the new sections — to more advanced topics such as naming conventions.

TGA has paid particular attention to the section on what documentation companies must submit when filing GMP clearance applications. This focus reflects the challenges TGA has faced in recent years. TGA estimates 60% of GMP clearance filings are incomplete. The significance of this figure to TGA's ability to quickly process the applications has ballooned in line with the number of filings. TGA received 140% more submissions last year than it did in 2010.

Faced with the high proportion of incomplete filings, TGA has significantly expanded the part of the guidance about identifying what documentation is needed. Tripling the size of the section has enabled TGA to provide a more thorough overview of what it needs and why. The documentation section is now subdivided by type of text — such as GMP certificate — and further split up into questions about each type of resource.

These questions cover not only the documents companies need to submit but why, and include pointers on things to pay particular attention to. For example, the GMP certificate section advises applicants that TGA will not accept redacted documents and those covering veterinary or investigational medicinal products.

TGA released the updated guidance alongside a tool to help applicants understand what evidence they need to submit. If, for example, a user states they want GMP clearance for a non-sterile API plant based in a country with which Australia has a mutual recognition agreement and they have a letter of access to evidence, TGA generates a page outlining the limitations of their documentation and pointing them to the part of the guidance that will help them to flesh out their applications.

Sponsors that fail to heed TGA's advice will struggle to obtain GMP clearance. The regulator used to contact companies that submitted incomplete applications, multiple times if necessary, to try to source the required documentation. That policy ended this week.

From now on, applications will automatically advance to the assessment stage. If TGA then finds a deficiency, it will ask for extra information by a certain date. TGA will review applications from sponsors that fail to provide the information in their incomplete state.

TGA Statement, GMP Guidance

Indian Government Files 2,000-Page Petition Arguing in Favor of ban on FDCs

The Indian government has submitted a 2,000-page report on fixed-dose combinations (FDCs) to the Supreme Court. Publication of the report precedes the court's judgement on whether to side with a lower court on the proposed ban on the sale of certain FDCs.

Government officials have used the lengthy document to make their case against a ruling made by the Delhi High Court last year which cleared drugmakers to continue selling hundreds of FDCs.

The document gets deep into the legal weeds that will ultimately dictate whether the Supreme Court thinks the government acted appropriately when it tried to ban 344 FDCs it found to contain irrational combinations of drugs. Specific points of disagreement include whether the government is allowed to take actions without consulting with the Drugs Technical Advisory Board and the Drugs Consultative Committee. The petition claims the High Court ruled "erroneously" on the question.

Officials also used the report to run through the process they followed in deciding whether to ban FDCs. Drugmakers affected by the ban have claimed the government failed to provide show cause notices, something the state disputes.

The Supreme Court's interpretation of these divergent positions will dictate whether the FDCs are banned, and potentially the process the government has to follow when taking actions in the future.

Government Petition

Pakistan Establishes Punishments for Violations of Drug Price Caps

Legislators in Pakistan have created powers to punish companies that overcharge for medicines. The law provides scope for hefty fines of manufacturers, importers and distributors that are found to have breached price ceilings.

The size of the fine depends upon the nature of the violation and violator. Manufacturers and importers have to pay "a fine equal to overcharged amount based on a country-wide average sale of the respective drug in the last financial three years," plus a 20% surcharge.

Pakistan has taken a different approach to distributors and retailers. If these organizations break the rules, they will receive a fine that is not directly tied to the amount they overcharged. Distributors face the biggest fine. Pakistan can fine distributors as much as 10 million rupees ($95,000).

The Drug Regulatory Authority of Pakistan (DRAP) published the legislative changes alongside a clutch of documents setting ceiling prices on different drugs. Gilead Sciences' Harvoni was among the medicines affected by the latest impositions of price caps.

Legislative Changes

CFDA Calls for Local Units to Intensify Efforts to Identify Drug Rule Violations

China Food and Drug Administration (CFDA) has asked its regional units to step up their efforts to learn of illegal drug activities. The request comes weeks after the Chinese government set out how to solicit and process evidence of wrongdoing.

CFDA's notice builds on the government documents on rewarding whistleblowers and investigating illegal activities by outlining what its local outposts should be doing. The notice breaks the strategy officials should be following up into three sections: strengthening leadership, ensuring rewards are in place and publicity and training.

Many of the suggested actions are broad and echo others made by CFDA, such as the demand that units strengthen their organization and leadership. Other actions proposed by CFDA include the use of internal training and intensification of publicity campaigns.

Local units can look to the government documents for more specific details. Those texts covered topics such as how to decide what to pay whistleblowers— sums of up to RMB 500,000 ($76,000) are mentioned — and what to do if two people provide the same information.

CFDA Notice (Chinese)

Other News:

The Central Drugs Standard Control Organization (CDSCO) has issued another notice about the production of oxytocin. The notice tells state drug controllers to list details of the production and sale of the hormone on their websites and asks wholesalers to keep records for inspectors. The focus on oxytocin stems from the scope of misuse of the drug. CDSCO Notice

TGA is planning to adopt version 3.1 of its electronic common technical document (eCTD) specification module at the start of next year. The agency framed the timing of the move as a response to its regulatory reform agenda and the incoming provisional approval pathway. TGA will publish the eCTD specification in the next two weeks. TGA Notice