Regulatory Focus™ > News Articles > 2019 > 6 > Asia Regulatory Roundup: Australia Extends GMP Clearance Filing Review Timelines to up to 120 Days

Asia Regulatory Roundup: Australia Extends GMP Clearance Filing Review Timelines to up to 120 Days

Posted 19 June 2019 | By Nick Paul Taylor 

Asia Regulatory Roundup: Australia Extends GMP Clearance Filing Review Timelines to up to 120 Days

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
 
Australia Extends GMP Clearance Filing Review Timelines to up to 120 Days
 
Australia’s Therapeutic Goods Administration (TGA) has extended its target processing timelines for good manufacturing practice (GMP) clearance applications. TGA will now take up to 120 working days to process compliance verification for sterile and biotech finished products.
 
GMP clearance, the mechanism for establishing the compliance of overseas manufacturing plants, is a long-standing problem for TGA. In 2017, TGA responded to a surge in the number of applications over the previous seven years by abandoning its commitment to process applications under mutual recognition agreements (MRA) within 15 days. At that point, TGA was typically taking around 40 days to process applications and reset its target time at 30 days.
 
TGA subsequently sought to streamline the GMP clearance process and cut the rate of incomplete filings, but it continued to struggle to cope with demand. Last year, TGA responded to the ongoing difficulties by reorganizing its approach to the prioritization of compliance verification submissions, opting to deal with them two to three weeks before the expiration of the current clearance. Compliance verification is the pathway used by manufacturers that are ineligible for MRA filings.
 
Now, TGA has provided compliance verification target processing timelines in response to feedback gathered at the TGA Industry Working Group on GMP. Industry representatives called on TGA to deliver predictable target processing times.
 
The result is four target processing timelines for different types of filings. TGA is aiming to process non-sterile active pharmaceutical ingredients (API) in 60 working days. The agency plans to spend 75 days on filings for sterile or biotech APIs. Timelines for finished products are longer still. TGA set the target timeline for non-sterile finished products at 90 working days. At 120 days, the longest timeline is for sterile and biotech finished products.
 
As when it extended the MRA timeline, TGA has framed the new compliance verification targets as the maximum timeframes. TGA aims to process filings before the end of the maximum timeframe, but has put the target in place so applicants know how long the process could take in the worst-case scenario.
 
TGA will include the new information in its GMP clearance guidance when it updates the document later this month. The current document lacks compliance verification target timelines, stating only that the wait depends on the “quality and completeness of the application” and the “complexity and/or risk of the manufacturing steps or products.”
 
TGA Notice
 
TGA Posts Guidance on Claims That Therapeutic Goods are ‘Natural’
 
TGA has published guidance on the use of “natural” and related claims when advertising medicines and medical devices to the public. The guidance requires companies to justify the use of the terms to help consumers understand what they mean in the context of advertisements for therapeutic goods.
 
Natural and related terms such as “naturally derived” and “sourced from nature” are widely used in the promotion of therapeutic goods and other products. TGA prohibits the misleading use of these terms through part of the advertising code that requires claims to be truthful, valid, accurate and substantiated. However, there was previously a lack of guidance on when TGA thinks the use of the terms is legitimate.
 
The guidance published this week seeks to address that gap. TGA’s guidance states that raw materials in products that make natural claims must be found in nature, for example in a plant, animal or bacteria. The raw material must also undergo “minimal processing,” a term that permits actions such as freezing, drying and solvent extraction, and be chemically unchanged by these activities.
 
As TGA clarifies in the guidance, the minimal processing requirement prohibits products based on synthetic raw materials from making natural claims. Such ingredients are chemically identical to substances found in natural sources but have undergone more than minimal processing.
 
Even products that meet these criteria are likely to need to feature caveats to natural claims. TGA will only permit unqualified natural claims in relation to products made solely of minimally processed ingredients found in nature.
 
The guidance also addresses the promotion of products on the basis that they “work naturally.” TGA will permit such claims in relation to products that invoke natural physiological processes but wants advertisers to avoid suggesting “that the good itself is natural.” The agency wants to see advertisers exercise comparable caution to avoid linking “natural” qualities to safety and efficacy, either overtly or implicity. That position prohibits the use of terms such as “nature knows best.”
 
TGA released a draft version of the guidance last year but made major changes in response to the feedback it received, notably by shortening and simplifying the document. The finalization of the text sets TGA up to publish guidance to help consumers understand what “natural” means in the context of therapeutic goods in the coming weeks.
 
TGA Guidance, More
 
CDSCO Calls for all Importers to Register on National Customs Portal
 
India’s Central Drugs Standard Control Organization (CDSCO) has asked importers of medicines to register on Icegate, an online national customs portal. CDSCO thinks the system will cut the time it takes to clear imports and exports.
 
Registration is required so CDSCO can link licenses, permits, certificates and other authorizations it issues to the appropriate importers and exporters. After registering, companies will receive the unique image reference numbers for their regulatory clearances. These numbers link the authorizations to the bill for customs clearance.
 
As well as accelerating import and export clearances, CDSCO thinks the system will further reduce the “physical interface” between it and the industry. CDSCO warned that failing to register may affect the issuance of clearances, adding that getting the system set up is a “top priority.”
 
CDSCO Notice, More
 
TGA Answers Industry Questions on Permitted Indications for Listed Medicines
 
TGA has responded to frequently asked questions from industry about its list of permitted indications for listed medicines. The document comes a little more than one year after TGA adopted the list to help ensure the quality of certain products that it does not evaluate before they come to market.
 
The frequently asked questions (FAQ) document addresses 22 queries across five categories. Most of the questions relate to the use of indication qualifiers to better align a permitted indication to the evidence on a particular product. The FAQ states the use of indication qualifiers is optional, unless a company wants to make such a conditional statement on its label or in other advertising.
 
Elsewhere in the FAQ, TGA outlines how companies can link indications, for example by stating that a product reduces symptoms of common cold and relieves cough. In that example, common cold is the parent indication.
 
TGA dedicates another section to indications for pregnancy and fetal development. In that section, TGA explains that “population” and “time of use” qualifiers are unavailable for pregnancy and fetuses as, “Pregnant women are a particularly vulnerable population group who may be susceptible to being persuaded that a medicine is imperative for the optimal health of their unborn child.”
 
TGA FAQ
 
Other News:
 
The Philippine Food and Drug Administration (FDA) has released materials intended to encourage the reporting of side effects in children and pregnant and breastfeeding women. The focus of the campaign reflects the potential for medicines to have different effects in these populations. FDA Notice, More
 

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