Asia Regulatory Roundup: Australia Looks to Establish Expedited Approval Pathway (20 September 2016)

Regulatory NewsRegulatory News | 20 September 2016 |  By 

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

Australia Moves Closer to Establishing Expedited Reviews

Australia has pushed its expedited review program closer to fruition by accepting the recommendations of an expert panel, which called for the creation of an expedited review pathway and an option to leverage overseas approvals when trying to bring a drug to market in Australia.

Lloyd Sansom, Will Delaat and John Horvath, the panelists tasked with analyzing Australian drug and medical device regulations, put changes to the pathways for registration of new chemical entities at the center of the reports and 58 recommendations they released. The model proposed by the panel would give applicants three options: Follow the traditional pathway, base the filing around an unredacted evaluation report from a foreign regulator or seek an expedited approval.

Having spent the past year evaluating the recommendations, the government has concluded it is in favor of enacting the reforms proposed by the expert panel. That is not the end of the process. While the Therapeutic Goods Administration (TGA) of Australia has a detailed picture of how it will design some of the pathways, it is yet to flesh out the details for others. Notably, the regulator still needs to establish the criteria by which it will decide whether a drug is eligible for expedited approval. TGA will consult with patients, healthcare professionals and drug developers about the specifics.

Plans for the overseas regulator-enabled pathway are more advanced. When active, the pathway will allow drug developers to file for approval on the basis of an unredacted copy of an evaluation report from a “comparable overseas regulator” and Australia-specific administrative information. Assuming the drug is suitable for the Australian population and conditions — and the proposed labeling and risk management tools are appropriate for the local clinical environment and requirements — TGA will perform an abbreviated evaluation of the application. 

The pathways are some of the many expert panel recommendations adopted by the government. Of the 58 recommendations, the government has rejected two. Changes to drug and device registration decisionmaking and expert committees were rejected on the grounds that the industry, patients and healthcare professionals all “strongly opposed” the recommendation. The government also rejected a proposed change to the status of the Advisory Committee on Medicines Scheduling, which the expert panel wanted to make a subcommittee of the Advisory Committee on Medicines.

Government Report

CFDA Posts Draft Guidance on Quality and Efficacy of Generic Drugs

China Food and Drug Administration (CFDA) has posted two draft guidance documents related to the adoption of conformance assessments for generic medicines. The texts cover the testing of generics to ensure efficacy and quality are consistent with their innovative comparators, and the process for handling copycats with different specifications than their reference products.

CFDA has used one of the guidance documents to set out how developers of generic drugs should approach the task of showing their development-stage molecule is comparable to the product it is trying to copy. With pharmacokinetics and bioequivalence being addressed in an existing guidance document, the draft focuses on situations in which it is necessary to run clinical trials of a generic and the process companies should follow when doing so. CFDA typically favors placebo-controlled trials, but will allow the use of active control arms in some circumstances.

In the other draft, CFDA addresses the reevaluation of the quality and efficacy of generics that are already on the market, particularly those that won approval despite having different specifications than their reference products. The document, which sets out the process for justifying a product’s specifications, supports CFDA’s adoption of a generic registration category that is consistent with the one in place at the US Food and Drug Administration. Both categories set constraints on the dosage form, route of administration and other characteristics of generic medicines.    

The draft guidance documents, which were published on successive days this week, form part of CFDA’s response to a move by the State Council to overhaul the generic medicine sector in China. In the past, systemic shortcomings have enabled generic medicines that differ from reference products to come to market. These differences range from variations in technical characteristics such as dissolution rates to major specifications such as the dose given. CFDA, at the encouragement of the government, is trying to improve the situation, in part through conformance assessments.

CFDA is accepting feedback on both drafts until the middle of next month.

Conformance Draft, More (both Chinese)

TGA Makes PPF Only Pre-Submissions an Established Option Following Pilot Test

TGA will make pre-submission planning form (PPF)-only filings a routine option when the pilot test of the approach concludes at the end of the month. The decision follows the collection of feedback on the piloted changes to the pre-submission phase of the filing process.

Officials began the pilot phase earlier this year to gauge the consequences of freeing companies from the need to file a “module 2 or equivalent” alongside the PPF. TGA thought the change to the requirements would cut at least one month off registration timelines while also reducing applicants’ workloads, but wanted to test the approach in the real world before changing its policy.

TGA is yet to post data on whether the modified pre-submission process had the anticipated effects, but whatever it has seen has persuaded it to continue offering the PPF-only option beyond the end of the pilot phase. The decision comes three months after the regulator called for the industry to offer feedback on the PPF-only approach.

Having committed to the approach, TGA is set to broaden the number of applications to which it can be applied. The pilot covered applications for new small molecules and biologics, biosimilars and generics. From February of next year, TGA will make the PPF-only option available to all Category 1 prescription medicine applications, a group that also includes filings related to label changes.

TGA Notice

Thai FDA Calls Meeting to Discuss Electronic Regulatory System

The Thailand Food and Drug Administration (FDA) has called a meeting to discuss the adoption of its electronic regulatory system. Officials want their peers in government and representatives of the food and drug industry to gather this week to learn about their digital initiatives.

At the meeting, the Thai FDA plans to frame the implementation of its online initiatives as part of a wider drive in the country to develop a digital economy. The overall goal of the drive as it applies to the Thai FDA, a scheme referred to as Skynet, is to digitize the regulator, an objective shared by many of its peers across Asia.

The breadth of this overall goal means Skynet is affecting many aspects of the Thai FDA’s interactions with the industries it regulates, a fact that is reflected in the scope of the meeting. Parallel sessions at the meeting will discuss the effect of the digitization drive on organizations involved with drugs, medical devices, food, imports and exports and other fields.

FDA Notice (Thai)

Other News:

TGA has told GI Dynamics to remove its EndoBarrier medical device from the market by 12 October. GI stopped a clinical trial of the device last year in response to the discovery of liver abscesses. Article



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