Asia Regulatory Roundup: Drugmakers Push Back on Data Requirements in Australia’s Provisional Approval Pathway (5 September 2017)

Regulatory NewsRegulatory News | 05 September 2017 |  By 

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Big Drugmakers Push Back Against Quality Data Requirements in TGA Provisional Approval Plan

A who’s who of leading drugmakers have raised concerns about the proposed data requirements for Australia's provisional approval pathway. The concerns center on the potential for the need to provide months of stability data and achieve good manufacturing practice (GMP) clearance to limit the impact of the the pathway.

The Therapeutic Goods Administration (TGA) wants to set up the provisional approval pathway to enable companies to cut the time it takes for highly-promising medicines to reach patients. TGA outlined its plans for the pathway in a consultation text earlier this year and asked companies for feedback on whether they foresaw difficulties with the proposed data requirements. Companies including AbbVie, Amgen, Johnson & Johnson, Roche and Sanofi highlighted essentially the same difficulties in their responses. 

Pfizer’s response to TGA is representative of the concerns these drugmakers have with the agency’s statement that “applications must include comprehensive quality and non-clinical safety modules that fulfil TGA’s mandatory data requirements.”

“Given the nature of provisional approval applications, a sponsor may not have complete quality data. Specifically, development of the final commercial process may still be ongoing and stability studies on final formulations may not be well advanced. There will need to be flexibility in approaches to defining acceptable evidence of quality to allow supply to patients. The timelines may also prove challenging for full GMP clearance to be available at the time of submission,” Pfizer wrote in its feedback on the proposal.

The industry was similarly united in its opposition to the proposal to have provisional registrations lapse automatically after two years. Amgen called the proposal an “unnecessary administrative burden.” Sanofi described it as “arbitrary.” Shire, Pfizer and other drugmakers also raised concerns with the proposal, although AbbVie said it “seems to be reasonable keeping in my mind that an extension can be sought.”

Multiple firms pointed to the experience of the European Medicine Agency’s (EMA) conditional approval pathway to support their arguments against the lapsing of registrations. As Shire noted, the initial two-year window plus the chance to secure two extensions gives companies a maximum of six years to generate the data needed to upgrade to a full approval. Data from EMA show 11 of the 30 conditional approvals granted over the first 10 years of the program were converted into full registrations. Three of these conversions took more than six years to complete.

Under the proposed TGA model, these drugs would have been removed from the therapeutic goods register before generating the data needed to win full approval. Also, with companies taking a median of 4.2 years to convert their approvals, many applicants are likely to need one or two extensions. This will add to the regulatory burden and uncertainty of participating in the program, although how severe these problems are will depend on how TGA handles the extension process.

TGA now plans to use the feedback it received during the consultation to prepare a guidance document for publication shortly before the implementation of the pathway.

Comment Submissions

CFDA Seeks Feedback on Plan to Standardize Handling of Overseas Inspection Program

China Food and Drug Administration (CFDA) has released guidelines for its overseas inspection program. The draft document details how regulatory officials should develop a risk-based annual inspection plan that considers the track records of importers when deciding which sites to visit.

CFDA wants its employees to consider multiple factors when assessing the risks posed by foreign production plants. These include reports of adverse events suggestive of problems with a drug, the findings of foreign regulatory agencies and the compliance records of manufacturers.

Publication of the guidance follows a period in which CFDA has sought to scale up its overseas inspection program, with mixed success. Last year CFDA identified a record 49 overseas producers as needing to be inspected but only visited seven of the targeted companies. CFDA cited “foreign affairs” as the cause of many of the unfulfilled inspection requests. The agency also encountered three companies that refused to consent to inspection and 12 that pushed back the date of CFDA’s visit to 2017 because they “cannot accept inspection” any earlier.

The guidance features provisions to prevent obfuscation by drugmakers and increase the chances of timely assessments. CFDA will class manufacturers that delay, impede or refuse inspection as noncompliant. Actions that could earn companies such censure include postponing inspections twice, limiting the time inspectors have at a site and concealing critical information. 

CFDA has also set limits on how long regulators and importers can take to complete certain steps in the inspection process.

The document is open for comment until 24 September.

CFDA Notice (Chinese)

Industry Broadly Welcomes TGA Drug Vigilance Plan, Pushes for Clarification on Specifics

TGA’s proposed medicine monitoring plan has received the broad support of the industry. The consultation suggests drugmakers are in favor of TGA’s plan to adopt a black triangle warning scheme similar to that in place in the European Union. 

One of TGA’s goals for the consultation was to assess whether the industry agreed with its proposed criteria for inclusion in the scheme. Drugmakers including Pfizer, Roche and Sanofi gave their broad support to the criteria, both through their own submissions and that of trade group Medicines Australia.

However, potential points of friction exist beneath the high-level support for the criteria and other proposals. Medicines Australia’s feedback highlights a lack of specifics in TGA’s proposals to date by making multiple requests for clarification across a wide range of topics. The question on the black triangle scheme alone prompted five requests for clarification.

TGA looks set to provide answers to some of the questions in future documents. The broadly-positive feedback has prompted TGA to push ahead with preparations for the implementation of the proposals. These preparations include the publication of a guidance document containing further details of the medicine monitoring process.

Comment Submissions

TGA Seeks Feedback on Relaxation of Rules on Advertising of Pharmacy-Only Medicines

TGA has started a consultation on a proposed framework for advertising of pharmacy-only drugs. The agency outlined its plans for schedule 3 medicines in a document covering improvements to the therapeutic goods advertising code.

The document takes its lead from eight advertising-related recommendations made by the expert review panel and the government's responses to them. One of the recommendations called for a review of the schedule 3 advertising guidelines, the current version of which came into force 17 years ago.

Many of the committees and processes referenced in the guidelines no longer exist. As importantly, perceptions of the merits of allowing advertising of pharmacy-only medicines has evolved. TGA gathered evidence of that evolution during an earlier consultation on schedule 3 drugs that found broad support for relaxing the rules on direct-to-consumer promotion.

One option now being considered by TGA is to allow the promotion of schedule 3 medicines unless it is deemed inappropriate for a particular drug or class of substances. Under this proposal, a working group made up of doctors, pharmacists, industry representatives and leaders from other groups would decide on a case-by-case basis whether to allow the advertising of each medicine.  

Draft Document

Other News:

TGA has committed to publishing reviews of the use of cannabis products to treat epilepsy, multiple sclerosis, nausea stemming from chemotherapy and HIV treatment, pain and palliative care. TGA Notice



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