Asia-Pacific Roundup: Malaysia’s MDA posts draft guidance on custom-made medical devices

RoundupsRoundups | 01 November 2022 |  By 

Malaysia’s Medical Device Authority (MDA) is seeking feedback on draft guidance about seeking permission to import or place custom-made medical devices on the market. The guidance covers the notification process for custom products that address the lack of adequate commercially available products.
 
In the draft, MDA explains the proposed general requirements for custom-made medical devices, which are intended for specific patients and manufactured in accordance with a written prescription. The written prescription must include the name of the patient, the design features that are unique to the device and the date on which the product will be used. MDA wants applicants to submit the notification form with the required documents, such as the written prescription and details of the device, and a non-refundable RM 300 ($63) administrative charge.
 
If all requirements have been met, MDA will issue a “no restriction letter” allowing the applicant to import or place the medical device onto the Malaysian market. If MDA requires additional information, the applicant will have 30 days to respond. MDA can revoke its letter if the applicant breaches the specified terms.
 
The notification conditions make the applicant fully responsible for handling the custom-made medical device, including supply chain activities, the submission of information to MDA and the retention of all information related to the technology.
 
MDA is accepting feedback on the draft until 11 November.
 
Draft Guidance
 
Pakistan’s DRAP finalizes guidelines on preparing Summary of Product Characteristics
 
The Drug Regulatory Authority of Pakistan (DRAP) has finalized its guidelines on the preparation of the Summary of Product Characteristics (SmPC) for drug products. DRAP has used the guidelines to outline the information that applicants should submit in the SmPC section of its common technical document.
 
While the SmPC section states that applicants should submit prescribing information along with the patient information leaflet for the finished pharmaceutical product, DRAP has created specific guidelines to provide further details. The guidelines feature multiple changes from the draft released for consultation earlier this year, while still retaining the same core advice.
 
DRAP has restructured the text, notably by moving the glossary from the end to near the start of the document and added extra details. The agency has expanded a section on legal requirements to link the guidelines to the DRAP Act 2012, which mandated the systematic implementation of internationally recognized standards, and revised some of its definitions.
 
The main part of the guidelines covers the information that must be submitted under the SmPC section and has only undergone relatively small changes. DRAP has removed a recommendation to avoid the use of decimal points, for example by listing a strength as 250μg rather than 0.25mg and added a statement that the “strength of biological products should be expressed in terms of mass units, units of biological activity or international units as appropriate.”
 
DRAP has also removed a line about the details manufacturers of active pharmaceutical ingredients should provide and sections on the submission of information about dosimetry and the instructions for preparation of radiopharmaceuticals. DRAP previously said the dosimetry and radiopharmaceutical information should be provided “if applicable.”
 
DRAP Guidelines
 
Indonesia’s BPOM provides update on testing of syrups for dangerous contaminants
 
The Indonesian Food and Drug Authority (BPOM) has provided an update on its response to the links between contaminated medicines and the deaths of at least 157 children from acute kidney injury and other complications.
 
BPOM has searched the registration data for medicinal syrups and drops to identify 133 products that do not use propylene glycol, polyethylene glycol, sorbitol or glycerin, the solvents implicated in the deaths. A total of 133 medicinal syrups and drops are safe to use, if the instructions for use are followed, according to the regulator.   
 
Officials have also looked at the registration data of 102 products used by patients that developed kidney disorders. They found 23 products do not use the solvents and therefore are safe to use. Seven products were declared safe to use after testing. Three products were found to contain levels of ethylene glycol or diethylene glycol, the contaminants linked to the deaths, above the safe threshold.
 
BPOM is still sampling and testing 69 products. The agency is also conducting intensified sampling and testing of products from the manufacturers of syrups that contain unsafe levels of the contaminants. The testing is occurring in parallel to in-person monitoring of the storage of syrup formulations and oversight of online platforms on which unsafe products may be sold.
 
BPOM Notice, More (Indonesian)
 
Counterfeit copies of Bayer, GSK drugs found in Pakistan
 
DRAP’s surveillance teams have found counterfeit copies of the antibiotics ciprofloxacin and azithromycin, purportedly made by Bayer and GSK, respectively, for sale in Pakistan.
 
Inspectors from Karachi identified the suspected products and sent them for analysis. The laboratory found the 10 products, two of which claimed to be made by Bayer and GSK, to be spurious. None of the companies listed on the labels manufactured the batches, leading DRAP to take action to remove the products from the market.
 
DRAP has told its regulatory field force to step up market surveillance and confiscate counterfeit batches of the 10 products. The regulatory agency has also asked pharmacies to immediately check their shelves and quarantine any affected batches, and asked healthcare facilities likely to be affected by the batches to be more vigilant.
 
DRAP Notice
 
Australia, Singapore authorize bivalent versions of Pfizer’s Comirnaty
 
Regulatory agencies in Australia and Singapore have authorized bivalent versions of Pfizer’s Comirnaty COVID-19 vaccine that are designed to protect against the original SARS-CoV-2 virus and forms of its Omicron variant.
 
In Australia, the Therapeutic Goods Administration (TGA) has provisionally approved a bivalent version of Comirnaty that protects adults aged 18 years and older against the original virus and Omicron BA.1. TGA provisionally approved Moderna’s rival bivalent COVID-19 vaccine at the end of August.
 
The Singapore authorization covers a different form of Comirnaty. Singapore’s Health Sciences Authority (HSA) granted interim authorization under the Pandemic Special Access Route for a bivalent version of Comirnaty that is designed to protect against the original virus and Omicron BA.4/5.
 
With BA.4/5 replacing BA.1 as the dominant strain during the development of the first bivalent boosters, Pfizer and Moderna began work on updated vaccines designed to protect against the circulating pathogens. Pfizer is still running clinical trials of the BA.4/5 booster, leading HSA to grant the vaccine interim authorization in part on the strength of human data on the BA.1 vaccine.
 
TGA Notice, HSA Notice
 
Other news:
 
TGA has issued fines of AU$253,080 ($161,841) over the alleged unlawful advertising of medicinal cannabis. Two clinics account for almost AU$240,000 of the fines after TGA accused them of promoting the use of unregistered prescription-only medicinal cannabis products. TGA Notice, More

 

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