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TGA Posts Guidance on Dossier Requirements for Biologicals
The Therapeutic Goods Administration (TGA) of Australia has released guidance on Class 2, 3 and 4 biologicals. TGA’s guidance sets out the information companies must include in dossiers for approval of low to high-risk cell- or tissue-based products.
Australian officials have spent the past few years reconsidering their approach to the regulation of cell- and tissue-based products in consultation with the industry. That process led to the adoption of a new regulatory framework at the start of July. Now, TGA has followed up on the framework with a guide to the dossier requirements for most biologicals.
TGA is allowing companies to follow either its biologicals dossier structure or the more widely used electronic common technical document (eCTD) structure. Whichever structure is used, TGA expects companies to include certain information to enable it to evaluate the application.
The information requirements vary across the different classes of biologicals. TGA wants developers of medium- to high-risk Class 3 and 4 biologicals to submit information about nonclinical and clinical development. The nonclinical section should show proof of principle, define the toxicological effects and establish the biological dynamics. TGA’s section on clinical development is less prescriptive, as the agency is tying the extent of data required for approval to the risks posed by a product.
Class 2 products are free from these requirements. Instead, developers of Class 2 biologicals must justify the intended use and predicted efficacy of their products. Like Class 3 and 4 submissions, Class 2 filings must also include a section on quality and manufacturing, although some of the requirements for low-risk products are less onerous.
TGA published the guidance alongside documents on other aspects of the regulation of biologicals. The agency also released guidance on seeking clearance for Class 1 biologicals, low-risk products that are subject to less stringent regulations because an appropriate level of external governance and clinical oversight is in place. TGA detailed the difference between the classes of biologicals in another document published this week.
, Classification Guide
, Class 1
China to Inspect all Vaccine Production Plants After Quality Scandal
Regulators are planning to inspect all the vaccine production sites in China in the wake of the quality scandal that has engulfed Changchun Changsheng Biotechnology. The wave of surprise inspections is intended to weed out substandard plants in a sector that has been dogged by failings in recent years.
Changchun Changsheng is the focal point of the latest scandal. A surprise inspection of Changchun Changsheng earlier in July found evidence that the Chinese manufacturer of rabies and DPT vaccines was falling well short of quality standards. Officials accused Changchun Changsheng of using expired active ingredients and running mice tests at the wrong point in the process. To cover up its failings, the company allegedly forged production data and issued false confirmations of tests.
The quality scandal looks set to lead to the arrest of senior executives and mid-level employees at Changchun Changsheng, and its impact is poised to spread beyond the company. Faced with a public outcry over the administration of ineffective vaccines to children, Chinese authorities plan to inspect every facility making prophylactic biological preparations in the country.
That far-reaching response reflects the government’s desire to improve public confidence in vaccines made in China. As it stands, confidence is at a low ebb following two major scandals in the past three years. The prior scandal hit in 2016, when the Chinese drug agency accused nine companies of selling expired or improperly stored vaccines. That scandal led to more than 190 criminal cases and plans to adopt a vaccine traceability system, centralize procurement and strengthen regulatory oversight.
The discovery of the failings at Changchun Changsheng during a surprise inspection shows aspects of the new system are working. However, authorities first identified substandard vaccines made by the company in November. Changchun Changsheng continued operating for months after that early sign of problems, until the discovery of forged data on 113,000 vaccines forced a recall and shutdown.
, NDA Notice
TGA Introduces Online System for Medicinal Cannabis Applications
TGA has introduced an online system to handle applications and notifications related to its special access scheme (SAS). The scheme enables the importation and supply of unapproved medicines that individual patients need.
As of 30 July, healthcare professionals can use the online system to submit SAS applications. TGA thinks the online system will reduce administrative burden. Notably, the system is designed to guide users to the appropriate SAS pathway based on the information they file, enabling people without detailed knowledge of the regulatory mechanism to secure access to medicines for their patients. The system also features a searchable database of products to reduce manual data entry and errors.
Healthcare professionals can use SAS to request access to a range of unapproved medicines, but the scheme has become synonymous with medicinal cannabis in Australia. The online system facilitates the streamlined process for accessing medicinal cannabis that TGA outlined in April.
TGA’s revised process is designed to free healthcare professionals from the need to contact state and national-level bodies when seeking access to healthcare professionals. In light of this, a tick box in the online system enables users to request that the information they submit is passed on to a state or territory health department, simplifying the dual-notification process. TGA and the state body will then independently assess the request and send outcome letters within 48 hours.
The creation of the online system follows a period of change and scrutiny for SAS. In August, TGA was forced to defend the scheme in the face of media reports that claimed excessive red tape was forcing patients to buy cannabis on the black market. On either side of those reports, TGA published a guide to the rules of SAS and strengthened the adverse event reporting requirements that apply to medicines sourced via the scheme.
TGA plans to phase out paper-based SAS submissions by July 2019.
, TGA Guidance
China Pushes Manufacturers of Valsartan Products to Take Recall Actions
The Chinese National Drug Administration (NDA) is pushing manufacturers of products containing the widely recalled valsartan active ingredient to take action. NDA has tasked provincial regulators with ensuring manufacturers take recall measures and publicize relevant information online.
Chinese officials have monitored the valsartan situation since Zhejiang Huahai Pharmaceutical told it about the identification of a carcinogenic impurity in the first week of July. Zhejiang Huahai stopped shipping the ingredient and initiated a recall. However, Zhejiang Huahai supplies the ingredient to six manufacturers of finished products, complicating the task of getting the drug off the market.
The five manufacturers that shipped products containing the contaminated valsartan have stopped using the ingredient and initiated recalls. Each manufacturer has also worked with IT companies to establish a traceability system for their valsartan products.
China’s Ministry of Health (MOH) issued a statement to spread and expand on NDA’s message. The MOH statement told medical institutions to cooperate with the recall and to stop using products containing the contaminated valsartan.
, MOH Notice
has published information to help manufacturers of listed medicines comply with their regulatory obligations. The document presents case studies showing how regulations apply to these products. TGA Guide