Asia Regulatory Roundup: TGA Tweaks GMP Inspection Closeout Process (17 May 2016)

Regulatory NewsRegulatory News | 17 May 2016 |  By 

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

TGA Updates Process for Closeout of On-Site GMP Inspections

Australia’s Therapeutic Goods Administration (TGA) has revised its process for handling the closeout of on-site good manufacturing practice (GMP) inspections. The updated process ends the practice of issuing close-out letters to manufacturers, with TGA choosing to communicate its closing messages in an inspection report instead.

TGA previously issued a separate closeout letter at the conclusion of each GMP inspection cycle. Now, the regulator will only provide an inspection report, in which it will detail the scope of the inspection, the process and systems that were assessed, a list of the observed deficiencies and an evaluation of the manufacturer’s response to the shortcomings. TGA will also use the letter to communicate the manufacturer compliance rating, the proposed dates for re-inspection and confirm the final outcome and closure of the current inspection. 

The inspection report marks the end of the TGA’s revised inspection process. TGA has updated the process in an attempt to make the resolution of shortcomings and closeout of inspections more efficient, while also aligning its practices with those of its global peers. A new process was tested early in 2015. TGA has also worked with the Technical Industry Working Group on GMP to refine the process, resulting in changes to everything from the way it reports deficiencies to companies to the format and content of the inspection report.

Manufacturers will now receive post-inspection letters within four weeks of the visit by TGA. It is TGA’s practice to point out deficiencies during inspections, so manufacturers will already have a good idea of the content of the letter. The manufacturer will then have four weeks to respond to the letter, although TGA may require a faster reply if it has identified serious compliance issues. In some cases, TGA may request objective evidence of actions taken by the manufacturer, although it typically will gather such verification during its next inspection. 

When TGA needs to gather its own objective evidence during re-inspection, it may extend the length of its visit to the facility. TGA could spend a whole extra day at sites where a large number of failings were identified during the original inspection. The final step is the aforementioned inspection report, which TGA will send out within four weeks of receiving a manufacturer's reply to its post-inspection letter.

TGA Statement

CDSCO Expands Pool of Candidates for Subject Expert Committees

The Central Drugs Standard Control Organization (CDSCO) has initiated the expansion of 29 of its expert panels. The expansion drive is intended to give CDSCO a larger pool of experts in vaccines, pharmacology, toxicology and other sectors to draw on when it needs to evaluate applications for approval of drugs, medical devices and clinical trials.

Drug Controller General of India (DCGI) Dr. GN Singh is seeking applications from experts in 29 fields who are willing to help regulatory officials assess filings for approval. Successful applicants will join the pool of experts CDSCO turns to when it needs to make up a Subject Expert Committee (SEC) to evaluate a filing. Applications for approval of global clinical trials, fixed dose combinations, medical devices and drugs are all put to an SEC, which is tasked with offering advice to DCGI to inform the final decision.

As it stands, CDSCO thinks it can benefit from gaining access to expertise in a wide range of areas. In some cases, the current shortfall in access to expertise may be attributed to the relative novelty of the subject matter in question. Electrical engineering, a field that has come to play a bigger role in healthcare in recent years, is one of the areas in which the regulator is seeking experts. Most of the fields are well established, though. Oncology, cardiology, rheumatology and dermatology are all on a list that covers the vast majority of the healthcare sector.

The regulator is offering to pay experts Rs 2,500 ($37) to attend a meeting. In return, experts are expected to sign up for a three-year term and provide feedback on proposals within six weeks, even if they are unable to attend the meeting. As well as being asked to opine on applications for approval, the experts may also be called on to contribute to the preparation of guidelines, definition of roadmaps for the research industry and any other task on which CDSCO needs the input of people from beyond its own ranks.     

CDSCO’s move to expand the panels follows shortly after the apex committee, which sits above SECs in the regulatory advice food chain, raised concerns about their understanding of certain requirements. In particular, the apex committee questioned whether SEC members have a comprehensive knowledge of the regulatory requirements relating to clinical trials. The apex committee has called for additional training of SEC members to address the concerns.

CDSCO Notice

DCGI Orders Recall of Sanofi Drug After Identifying Substandard Batches

The DCGI has ordered the recall of four batches of Combiflam, a mix of paracetamol and ibuprofen sold by Sanofi. DCGI took the action after identifying substandard batches of the painkiller for the second time this year.

In a statement, Sanofi attributed the recall to the discovery of a delay in the time it takes for the drug formulation to disintegrate. The issue is thought to affect four batches of Combiflam, two of which have already been fully recalled. A recall of the other two batches is ongoing. Sanofi was also forced to recall batches of the painkiller in February, but despite the repeated Combiflam quality problems, the company is publicly confident it has the matter under control.

“[We have] analysed the issue and appropriate remedial steps have been taken to ensure that the tablets disintegrate within the specified timelines,” the company said in a statement to the Bombay Stock Exchange. Combiflam is manufactured at Sanofi’s facility in Ankleshwar, Gujarat, a production plant with the capacity to produce 5 billion tablets a year. In addition to Combiflam, the Ankleshwar site manufactures 11 tablets including Sanofi’s allergy drug Allegra and antibiotic Tavanic, plus six active pharmaceutical ingredients and intermediates.

Combiflam is the only Sanofi product to be the subject of a DCGI quality alert in at least the past 12 months. In April, DCGI found fault with the quality of 16 products from other manufacturers, including Macleod Pharma’s Orcerin. CDSCO failed Orcerin on the grounds of “related substances” following testing of the product at its laboratory in Kolkata.

Sanofi Statement, Business Standard

Other News:

China Food and Drug Administration (CFDA) has begun a consultation on the review and approval of drug packaging and excipients. CFDA’s proposal covers the submission of details about critical process parameters and other information. The regulator has given the industry until 23 May to comment on its plans. CFDA Notice (Chinese)

The CFDA Medical Device Evaluation Center has initiated a staff recruitment drive. CFDA is planning to hold a multi-step recruitment process, which will put potential new hires through a written test, interview and physical examination. The regulator is looking to hire 60 staff. CFDA Notice (Chinese)

DCGI Dr. GN Singh has alerted state drug controllers to orders made by the Delhi High Court in relation to the attempt to ban 344 fixed-dose combination products. The first order, dated 4 April, tells state regulators to refrain from enforcing the ban. DCGI Letter


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