Asia Regulatory Roundup: TGA Brings 6 Guidance Documents in Line With PIC/S Guide to GMP

RoundupsRoundups | 22 January 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India Prohibits 80 FDCs After Prolonged Legal Dispute
India has published legislation banning the production of 80 fixed-dose combinations (FDCs) it thinks are likely to pose a threat to humans. The action is the latest salvo in a long-running fight over the rationality and legal status of hundreds of FDCs sold in India.
A subcommittee formed by the the Drugs Technical Advisory Board opined on the rationality of the FDCs in 2015. According to the new legislation, the subcommittee believed eight of the FDCs to be “absurd.” These FDCs and 286 others were featured that year on a list of products India tried to ban on the grounds that it deemed them to be irrational. Organizations including Pfizer challenged the ruling, leading to a legal dispute that held up India’s attempts to get the products off the market.
Having worked through the legal process and resulting requests to review the FDCs, the government now thinks it is in a position to prohibit the production and distribution of 80 products with immediate effect. The government thinks the combinations featured in the FDCs lack therapeutic justifications and are “likely to involve risk to human beings.”
One of the combinations deemed “absurd” by the subcommittee features activated charcoal, fungal diastase and lactic acid. Another of the “absurd” FDCs is made up of chlorzoxazone, paracetamol, ibuprofen and diclofenac sodium.
Manufacturers brought these FDCs and other now-prohibited products to market without generating the typically required datasets by going through state licensing authorities, not the Central Drugs Standard Control Organization. The presence of the loophole led to the proliferation of FDCs that had questionable therapeutic justifications and minimal data to quash these doubts. India’s efforts to clamp down on such products date back more than five years.
Having seen those efforts delayed and thwarted, the government has now succeeded in getting some of the 294 FDCs it targeted pulled from the market.
Gazette Notification
TGA Adopts Stop Clock Process as Struggle Against GMP Backlog Continues
Australia’s Therapeutic Goods Administration (TGA) has changed its approach to tracking the time it takes to process good manufacturing practice (GMP) clearance applications. The new approach is a response to ongoing problems with the quality of applications and their effect on processing times.
The prevalence of substandard, incomplete compliance verification in GMP clearance applications became a problem for TGA a few years ago. These applications made up a small part of TGA’s workload around the start of the decade, but the number received increased by 140% between 2010 and 2016. The rapid rise in the number of applications put TGA’s system for processing the filings under strain, resulting in the buildup of a backlog of submissions.
TGA has changed its own process and significantly expanded its guidance to applicants in a bid to get on top of the situation. The changes have had some positive effects, notably a 40% decrease in the size of the backlog, but TGA continues to face difficulties. Despite TGA revising its guidance and taking a tougher line on incomplete filings, around 40% of the submissions it receives are incomplete.
With a significant minority of submissions still missing fees or evidence, TGA has begun to stop the clock when it needs to request money or information from companies. The change means TGA will no longer include these lulls in the processing of applications in its calculations of how long it takes it to handle GMP clearance submissions. TGA only used to stop the clock during the assessment stage.
TGA picked out three instances in which it will now stop the clock. Filings by applicants that fail to select the applicable fees during the submission process will immediately be subject to a stopped clock. TGA will again stop the clock if the applicant fails to submit all the evidence during the receipting stage, and again if deficiencies are identified during the assessment stage.
The extension of the stop clock policy to the whole process should reduce TGA’s calculations of how long it is taking to process GMP clearance applications. TGA focused on other consequences in a notice to disclose the change, claiming that it will “further improve the efficiency and transparency of the GMP clearance process” and “ensure that applicants who provide complete applications are not disadvantaged.”  
TGA Notice
TGA Brings 6 Guidance Documents in Line With PIC/S Guide to GMP
TGA has updated six guidance documents to bring them into line with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP guide, PE 009-13. Most of the documents relate to the quality and production of complementary medicines.
The Australian regulator published the original versions of the five complementary medicine texts in 2009 and 2010. TGA only made small changes to the documents in the following years. That changed this week, when TGA published version 2.0 of each document. In each case, TGA has changed the title and scope of the document while ensuring it is consistent with the PIC/S guide to GMPs.
The current version of the guide, which was released at the start of 2017, features annexes on the production of herbal medicines — also known as complementary medicines — and medicinal gases, the topics covered in the documents TGA updated this week. The annexes set out how the unique features of herbal medicines and medicinal gases affect approaches to GMP compliance.
TGA’s guidance documents draw on the annexes and other parts of the GMP guide to provide advice on product quality reviews, sampling and testing, supplier assessment, ongoing stability tests and process validation for complementary medicines. The sixth document covers medicinal gases.
In revising the documents, TGA has retained some core elements while making substantial changes elsewhere. For example, the supplier assessment guidance features a similar process for qualifying partners. Yet, while the process still starts with understanding the nature of the packaging or starting materials and ends with periodic review, many of the details between those points have changed.
The new guidance states that manufacturers of complementary or listed medicines do not need to establish formal GMP or technical agreements with suppliers. Version 1.0 of the text said nothing about the need for technical agreements.
Supplier Guidance, TGA News
MFDS-Funded Pharmacovigilance Survey Identifies Need for Harmonization in Asia Pacific
Academic researchers funded by South Korea’s Ministry of Food and Drug Safety (MFDS) have found “substantial variations” in the handling of pharmacovigilance across Asia Pacific. The researchers see the findings as a stimulus for harmonization in the region.
The study, which was published in Pharmacoepidemiology & Drug Safety, was based on the findings of a survey sent to the heads of pharmacovigilance agencies in 21 countries in Asia Pacific. Fifteen of the agencies responded.
Six of the respondents said their countries had no adverse drug reaction forms for the general public. Four of the countries lack regulations covering responsible persons for pharmacovigilance. Another nine countries do not have united databases that integrate pre- and post-market adverse events.
In light of the differences, the researchers said “efforts to reduce variations in the [pharmacovigilance] administration and regulation are warranted.” To date, harmonization efforts have been hampered by the diversity of cultural and medical practices in the surveyed countries, which include nations as different as the United States and Papua New Guinea. 
PDS Paper


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