As part of its effort to closely align its regulatory approaches with EMA, ICH and the US Food and Drug Administration, TGA has adopted around 370 international scientific guidelines to date. The latest batch of guidelines up for adoption is a mix of replacements for existing international texts used by TGA and new documents that the agency thinks can help sponsors to comply with Australian legislation.
“While international scientific guidelines that are adopted in Australia are generally not mandated by legislation, they provide guidance to sponsors to assist them to meet the legislative requirements. Any deviation from a guideline relevant to an application to register or vary the registration of a medicine must be justified,” TGA wrote.
More than half of the documents are new, as opposed to being updates of existing texts, although TGA sees some of them as complementing its current portfolio of guidelines rather than covering wholly new topics.
The list of new documents includes ICH Q12, a text covering technical and regulatory considerations for pharmaceutical product lifecycle management, and questions and answers on EMA guidance for setting health-based exposure limits in risk identification in the manufacture of different medicinal products in shared facilities. EMA adopted the two documents in 2018 and 2020.
For each of the documents, TGA is only asking whether the respondent supports or opposes adoption, or if the text is not applicable to their work. There is an opportunity for respondents to share other relevant information to explain their support or opposition to the proposal.
TGA is accepting feedback until 20 February.
TGA posts warning about repackaging of COVID-19 tests, reviews impact of variants
TGA has issued a warning about the repackaging or relabeling COVID-19 rapid antigen tests. The agency is reminding the industry of the rules on repackaging and the potential punishments for noncompliance.
As the updated guidance states, distributors and vendors should only repackage and relabel a medical device at the direction of the sponsor. The process must be authorized by the manufacturer and covered by a formal quality agreement. Distributors and vendors can then repack and relabel tests in a secure, controlled environment that meets the manufacturer’s documented procedures.
TGA used the update to state the need to provide instructions for use with rapid antigen tests, adding that a retailer, distributor or other person who supplies a kit without appropriate instructions may be breaking the law. The agency also clarified that not all tests are eligible for home use.
“Point of care tests do not have approved instructions for use that are suitable for consumers who will be testing themselves at home. In the absence of approved instructions for use that are suitable for home use, suppliers of rapid antigen tests that are not suited for home testing run the risk of breaking the law by supplying a rapid antigen test without appropriate instructions for use,” TGA wrote.
The update lacks details of what prompted TGA to remind stakeholders of the rules, but is transparent about the next step for organizations that fail to meet the requirements. TGA plans to investigate any incidents, which it is encouraging people to report, and it will follow a process that could lead to fines of AU$ 4.4 million ($3.2 million).
TGA published the update days before releasing details of a post-market review of antigen and rapid antigen tests. The agency is assessing whether existing variants have affected the performance of the tests. Testing will start on 15 January and add to emerging evidence about the effect of omicron on test sensitivity.
TGA Notice, More
Philippine FDA starts consultation into the authorization of in vitro diagnostics
The Philippine Food and Drug Administration (FDA) is seeking feedback on the rules and procedures for the issuance of in vitro diagnostic (IVD) authorizations. The draft sets the stage for the registration of IVDs over a two-phase process.
In the first phase, which is set to be implemented six months after the draft proposal takes effect, FDA will register IVDs based on its latest list of registerable diagnostics. That phase will see the notification, a process of approval, of all Class A IVDs, which covers the lowest-risk products, and Class B, C and D IVDs that are not included in the latest FDA list of registrable IVDs.
FDA will use the second phase to register all Class B, C and D IVDs. The notiﬁcation of Class B, C and D IVDs will stop during the second phase. The agency is yet to publish a schedule for the implementation of the second phase.
The rest of the draft document provides guidance on the application process, sets out the associated fees and discusses the grounds for rejection of applications and the cancellation of the notification and registration of IVDs.
TGA highlights limitations of pulse oximeters and the effect of skin pigmentation
TGA has published a notice about the limitations of pulse oximeters and the effect skin pigmentation can have on their performance. The Australian agency is concerned that overreliance on the devices could cause patients to receive suboptimal care.
COVID-19 has increased the use of pulse oximeters, which estimate blood oxygen levels to provide insights into the health of people with respiratory diseases. The increased use has resurfaced existing concerns about the potential for factors including skin pigmentation to affect accuracy in ways that may cause low oxygen levels to go unrecognized and untreated.
TGA is advising healthcare professionals that pulse oximeter devices may not accurately detect low blood oxygen. The agency recommends clinicians review the device label to understand the accuracy of the products they use and consider the limitations when using pulse oximeters to inform care decisions.
“Interpret pulse oximeter readings within the context of a patient’s entire clinical presentation and incorporate other clinical information into decision-making. Use serial readings and note trends. Recognise that the systems-level risk associated with this issue has increased because of the respiratory pandemic and increased reliance on home-based management,” TGA said.
DRAP posts draft legislation on the qualifications and duties of federal inspectors
The Drug Regulatory Authority of Pakistan (DRAP) is seeking feedback on draft legislation covering the qualifications and duties of federal inspectors.
After establishing the education and practical experience needed to become a federal inspector, the draft lists the primary duties of the role. The top duties are to inspect facilities used for the production and testing of therapeutic goods and to send a detailed report after each assessment. Inspectors are also expected to investigate complaints and pursue prosecutions in response to violations of the rules
The rest of the draft legislation covers the forms inspectors need to complete in relation to different activities and other details of their roles, such as the ban on the disclosure of confidential information acquired during the course of their duties. Inspectors may only disclose confidential information as part of their official business and when required by a court of law.
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