TGA Assessed Listed Medicines Evidence Guidelines

The assessed listed medicines pathway provides sponsors with a new method of listing a product in the Australian Register of Therapeutic Goods (ARTG). The new pathway sits between the current listed (lower risk) and registered (higher risk) pathways. It enables sponsors to list products with higher level indications than permitted in standard listed medicines without having to meet the extensive requirements for full registration. This is provided that assessed listed medicines have robust scientific evidence to support the efficacy of the product, and this evidence is pre-market assessed by the TGA. Medicines that have undergone pre-market assessment and approval by the TGA have a unique AUST L(A) number, and may carry a claim that the product's efficacy has been assessed for the approved indications. There are three application categories for assessed listed medicines which have different evidence requirements depending on the level of efficacy evaluation This document provides guidance for the evidence requirements for all application categories, however a majority is dedicated to L(A)3 applications as these products require a de novo evaluation of efficacy.   Source: Assessed LM guidelines

TGA Conducts Review of Listed Medicines With Traditional Indications

The Therapeutic Goods Administration will be initiating targeted compliance reviews of a selection of listed medicines that use traditional indications. (Traditional indications are statements that describe the specific therapeutic use for a medicine based on evidence of a history of medicinal use). If you are a consumer, please be aware that this is part of TGA’s normal review process and there is no immediate concern associated with the use of listed traditional medicines. TGA recommends that If you are a sponsor of a listed medicine with traditional indications, you are encouraged to re-evaluate the evidence you currently hold; and to reconsider the indications made for your medicines with reference to the ‘evidence guidelines for listed medicines’. TGA will be conducting desktop compliance reviews for a selection of listed medicines with traditional indications in the second half of 2018. Some will be selected randomly and others will be selected on the basis of regulatory intelligence.   Source: Traditional indications review

Submissions Received: Discontinuing Pre-Market Evaluation f Herbal Component Names (HCNs)

The TGA has published submissions made in response to the November 2017 public consultation paper, “Consultation: Discontinuing pre-market evaluation of Herbal Component Names (HCNs)”. A total of 7 submissions were received. All respondents that gave permission to be published on the TGA website are now available in PDF format.   Source: Herbal component names

Discontinuing Pre-Market Evaluation of Herbal Component Names

Where a herbal ingredient comprises of chemical constituents, these chemical constituents are referred to as "herbal components". A Herbal Component Name (HCN) for use in listed medicines is a name for a herbal component of its parent herbal ingredient. HCNs are not standalone active ingredients for use in listed medicines. Certain herbal components are mandatory to declare in listed medicine applications. These mandatory herbal components are identified in the Therapeutic Goods (Permissible Ingredients) Determination, and are mandated by the Poisons Standard or for safety reasons. There is no legislative requirement to use non-mandatory herbal components for listing a medicine on the ARTG. Sponsors will no longer be able to submit new HCN applications for pre-market evaluation effective immediately. After 1 October 2018, sponsors will not be able to select HCNs from the TGA list of approved HCNs for use in new listings. The TGA will continue to work with industry to discontinue pre-market evaluation of HCNs.   Source:  Herbal component names

TGA Consultation on Proposed Therapeutic Goods Advertising Code Guidance

The Code is the key advertising compliance standard that sets out minimum requirements and underpins the regulatory framework for the advertising of therapeutic goods to the public. The Code addresses several recommendations from the Expert Review of Medicines and Medical Devices Regulations that were agreed by Government. The TGA is seeking input from interested parties on the revised version of the guidance to support the Code. This consultation closes on 4 October 2018.     Source: Advertising code consultation

TGA Updates Compositional Guideline Template

A compositional guideline is a summary of descriptions, tests and limits that define the composition and characteristics of a substance approved for use in listed medicines as either an active substance or an excipient. This template is for prospective sponsors and substance manufacturers to supply with their applications.   Source: Compositional guidelines

TGA Announces Final Decisions Amending The Current Poisons Standard for Cannabis Products

The final decision of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the Schedule 4 entry for cannabidiol, and the Schedule 8 and Appendix K entries for tetrahydrocannabinols and cannabis in the Poisons Standard.  Source:  Cannabis regulation

TGA Updates on GMP Clearance Application Forms

These notices are for sponsors who make GMP clearance applications. Following updates to the GMP clearances forms, the TGA is continuing to monitor and review them to ensure improved user experience. The TGA has become aware of several issues, and fixes are scheduled to be implemented in August 2018.   Source: GMP clearance

TGA Recall - Durex Real Feel Condoms (6 pack)

Reckitt Benckiser (RB), in consultation with the TGA, is conducting a recall of one batch of Durex Real Feel polyisoprene (non-latex) condoms as testing has found this batch will likely not meet specifications at the end of its shelf-life in 2021. The affected condoms come from batch number 1000432443 (expiry January 2021). No other batches are affected by this issue. The recall followed RB's in-house durability testing during which the affected batch was heat treated to simulate three years of shelf-life ageing and failed subsequent pressure tests. There is no immediate safety concern for consumers and there have been no adverse events reported in Australia regarding this batch of condoms.   Source: Condom fail

TGA Safety Advisories—   Source:

Fairy capsules: the capsules contain the undeclared substance sibutramine

G Female Oral Tablets: the tablets contain the undeclared substance sildenafil

Liangzern Dietary Supplements: the tablets contain the undeclared substance sildenafil

Germany Niubian tablets: the tablets contain the undeclared substance sildenafil

Rhino 8 Platinum 8000 capsules: the capsules contain the undeclared substance sildenafil

TGA Expands List of Comparable Overseas Regulators for Medical Device Applications

The TGA is expanding the range of international assessments and approvals from comparable overseas regulators that sponsors can choose to provide when submitting their applications for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG). TGA is also increasing the use of assessment reports as the basis for abridgement of the assessment of an application for a TGA conformity assessment certificate.   Source: Medical devices 1(See also related story:  Application Requirements for Medical Devices - Preliminary Assessment  Medical devices 2 )

TGA Updates Status of Essure Contraceptive Device

The Essure contraceptive device was cancelled from the Australian Register of Therapeutic Goods (ARTG) on 9 February 2018. Since the device began supply in Australia in 1999 until 6 August 2018 the TGA has received 59 adverse event reports relating to women implanted with the Essure device.   Source:  Medical device scandal

Vitamin Supplementation Comes Under Scrutiny

Dr. Derek Muller is the creator of popular YouTube channel Veritasium and has investigated vitamins and whether they really are good for humans. In a recent documentary Vitamania: The Sense And Nonsense Of Vitamins televised on SBS, Dr Muller said there were about 85,000 vitamin products on the market and people spent about $100 billion on vitamin supplements around the world. “We are looking at one billion people who regularly take vitamins or supplements — that’s a lot,”. Dr Muller is not out to debunk vitamins and he said they can improve people’s health in some cases. “I want us to be more nuanced in our understanding of these substances.” His new documentary, was screened in sessions around Australia between July 28 and August 3.   Sources: Charis Chang, Vitamin scrutiny ; Vitamania  (Editor’s note:  Robert Forbes was invited to contribute to Vitamania and his comments can be read here: RFA backgrounds Vitamania )

TGA Responds to Vitamania

On the evening of 12 August 2018, the documentary Vitamania premiered in Australia. The documentary explores the role of vitamins and vitamin purchases around the world. To provide context for the film, the TGA describes here how they regulate vitamins in Australia. Source: TGA Vitamania

Botanic Adulterants Prevention Program

Three leading nonprofit organizations—the American Botanical Council (ABC), the American Herbal Pharmacopoeia(AHP), and the University of Mississippi's National Center for Natural Products Research (NCNPR)—have initiated a large-scale program to educate members of the herbal and dietary supplement (complementary medicines) industry about ingredient and product adulteration. Responsible parties in the herbal and dietary supplement community have become increasingly concerned about the suspected and confirmed practice of adulteration of numerous ingredients. The existence of adulteration raises questions about the identity and quality of some popular herbal ingredients sold in dietary supplements in the United States and in other botanical products (e.g., medicines, cosmetics, etc.) in global markets. For a complete summary of all activities of this programme, please visit Botanical Adulterants Index page    (Editor’s note: For the most recently published example of this programme, please read the “Bulletin on Boswellia Resin Adulteration - adulteration and substitution of boswellia with resins from related species” Boswellia adulteration )

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