Asia-Pacific Roundup: Pakistan’s DRAP issues draft guidelines for good cold chain management
The Drug Regulatory Authority of Pakistan (DRAP) has released for consultation draft guidelines on good cold chain management practices for temperature-sensitive drug products. DRAP created the text to set out the principal requirements for the safe storage and distribution of cold chain medicines.When finalized, the 43-page document will serve as DRAP’s first dedicated guidelines on shipping time- and temperature-sensitive pharmaceutical drug products (TTSDPs). The DRAP document applies to drug product manufacturers, importers and exporters and their active pharmaceutical ingredients, including wholesalers, distributors, transporters, and retail outlets for storage and distribution. The guidelines cover approved drugs, investigational medicines, and physician samples.
DRAP has based the draft guideline on the World Health Organization (WHO) Annex 9 Model guidance for storing and transporting time- and temperature–sensitive pharmaceutical products. The draft uses the same structure as the model guidance and copies some sections verbatim but diverges significantly in parts from the WHO text. A section on importation, for example, is almost completely rewritten.
Through the guidelines, DRAP wants to emphasize “the increased importance of pharmaceutical cold chain management as a result of changing product environment,” as well as the requirements for good storage and distribution practices, current regulatory trends and issues related to quality management, risk assessment factors and temperature monitoring systems.
The goal is to ensure TTSDPs retain their quality throughout the supply chain and focus on monitoring compliance of a product with suitable quality specifications throughout its shelf life and ensuring it is shipped and stored under the recommended conditions. DRAP has divided the guidelines into sections on importation, warehousing sites, storage buildings, temperature-controlled storage, transport and delivery, stock management and other topics.
Temperature-controlled storage is one of the larger sections. In the section, DRAP references relevant texts from the United States Pharmacopeia before listing actions that owners of temperature-controlled storage need to take, such as ensuring that net storage capacity is sufficient to accommodate peak stock levels and preferably using thermostatic temperature control systems.
DRAP’s preference for thermostatic temperature control systems reflects concerns that “thermometers provide only limited and discontinuous temperature information.” As such, the agency ideally wants all sites to use continuous recording devices for all temperature-controlled rooms, cold rooms, freezer rooms, refrigerators and freezers. The devices should be in areas where the greatest variability in temperature is expected and accurate to plus or minus 0.5 °C or better.
The guideline, which DRAP uploaded on March 27, is open for comment for 15 days.
Draft Guidelines
Japan’s PMDA shares precautions for cleaning and disinfection of gastrointestinal endoscopes
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published guidelines on the cleaning and disinfection of gastrointestinal endoscopes to reduce the risk of contamination and damage to the devices.
Concerns about the risk of cross-contamination when reusing gastrointestinal endoscopes and other similar devices have mounted in recent years, leading regulatory agencies and professional bodies to set out best practices for cleaning the products between uses.
The PDMA precautions are based on cases when cleaning has gone wrong. Two cases describe the risk of cleaning parts remaining in the channel of the endoscope. In one case, the brush fell into the patient’s body during surgery. To mitigate that risk, PMDA is asking people who clean endoscopes to check if any of the brush has broken off before providing the device for use.
Other cases relate to the risk of microbial contamination. The guide advises users about signs that an automated endoscope reprocessor will fail to clean the device adequately and about the risk of using a disinfectant solution below the effective concentration.
“Sufficient disinfection effect may not be obtained if disinfection with an appropriate concentration of disinfectant is not performed for an appropriate immersion time. It may cause inadequate disinfection of the endoscope and result in cross-infection,” the PMDA guide states.
PMDA also asked users to check the electronic package insert of each product, instruction manual and academic society guidelines on cleaning gastrointestinal endoscopes.
PMDA Guide
Australia’s TGA gains new powers to reduce the impact of medicine shortages
Australia’s Therapeutic Goods Administration (TGA) can now approve the temporary import or supply of overseas-approved medicines as a substitute for one in short supply if it has been previously registered in Australia.
Previously, TGA could only grant temporary approval for importing and supplying a substituted overseas medicine if the Australian medicine was currently included in the Australian Register of Therapeutic Goods (ARTG). Under the new rules, TGA can approve the use of medicines even if the medicine has been discontinued, suspended or canceled from the ARTG.
Australia enacted the changes alongside revisions to the requirements around updating and resolving shortages. TGA expects the clarification of the requirements to improve the accuracy of the information it publishes in its Medicine Shortage Reports Database.
TGA Notice
Malaysia’s MDA to start withdrawing incomplete medical device applications after 30 days
Malaysia’s Medical Device Authority (MDA) will soon start withdrawing incomplete applications for new and re-registered medical device registrations and change notifications after 30 days.
The new policy takes effect on 1 April, but MDA has established a transitional period to defer the rule’s full implementation until 1 May. Once the rule is in full effect, MDA will send back incomplete submissions and give the applicants up to 30 working days to provide the required information and documents.
MDA will drop the submission if the applicant fails to provide “any information, particulars or documents as required” within 30 working days. MDA asks applicants to ensure the information or documents “are correct and completed” before filing.
The agency will not refund the application fee for withdrawn submissions. Applicants can resubmit but will need to pay the fee again. The information applicants must include in submissions is covered by other documents, such as the Medical Device Act 2012.
MDA Notice
Other news:
China’s National Medical Products Administration (NMPA) has granted conditional market approval for the oral antiviral drug RAY1216 in the treatment of COVID-19. The approval covers the use of Guangdong Zhongsheng Pharmaceutical’s RAY1216 in the treatment, under medical supervision, of adults with mild and moderate symptoms of COVID-19. NMPA Notice
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is working to increase awareness of the risk of abnormal uterine bleeding when taking certain blood thinners. Medsafe Notice
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