The current version of the guidance, published in 2018, describes the process for applying for a CFS for an export-only medical device. MDA plans to expand the scope of the document, titling the draft second edition of the guidance “requirements for application of certificate of free sale, manufacturing certificate and certificate of free sale for export only medical devices.”
That expanded scope is reflected in a section that features tables of requirements for obtaining medical device certificates. The existing document features one table that lists requirements companies need to meet when filing for CFS for export-only medical devices. That table is largely unchanged in the proposed draft, but MDA has added two new tables that describe the requirements for CFS and manufacturing certificates.
Companies applying for a CFS need to provide a copy of the establishment license, registration certificate and details of the product covered by the filing. The requirements for manufacturing certificates include all the CFS materials, plus additional information such as a copy of the quality management system certificate. The list of requirements for export only CFS is much longer.
Other changes to the existing guidance include the addition of example fee calculations for CFS and manufacturing certificates, plus a new section on application amendments. The new section states that no amendments are allowed once a certificate is issued. Companies that want to make changes will need to submit a new application. The draft also features new annexes.
MDA is accepting feedback on the draft guidance until 13 January.
CDSCO asks companies to submit summaries of their Indian pharmacovigilance systems
India’s Central Drugs Standard Control Organization (CDSCO) has asked human vaccine companies to file summaries of their “established” pharmacovigilance systems and, if available, self-inspection reports.
The New Drugs and Clinical Trials Rules, 2019 require the importer or manufacturer of any new drug sold in India to have a pharmacovigilance system for collecting, processing and sending adverse drug reaction reports to the central licensing authority. The pharmacovigilance system must be managed by qualified and trained personnel, and a medical officer or pharmacist trained in collecting and analyzing adverse drug reaction reports must oversee handling of the data.
CDSCO wants to know if vaccine manufacturers and importers are complying with the requirements, leading it to ask companies to submit certain documents “at the earliest” opportunity. The regulatory agency wants to receive summaries of pharmacovigilance systems, details of the officer in charge of the data and self-inspection reports, when available.
Vaccine manufacturers and importers are required to maintain a pharmacovigilance system and staff as they “may be subject to inspection at any time for verification of compliance,” CDSCO wrote in its notice about the request. Requesting the documents will enable CDSCO to check compliance with the rules and thereby audit the pharmacovigilance practices of the human vaccine industry.
TGA relaxes rules on travelers bringing animal or human derived injectables into Australia
Australia’s Therapeutic Goods Administration (TGA) has relaxed its rules on bringing injectable medicines containing material of human or animal origin into the country.
Previously, travelers needed to contact an Australian doctor before entering the country with most injectable medicines containing material of human or animal origin, except for insulin. The doctor then needed to contact TGA to get permission for the traveler to enter the country with the medication.
“This placed an unnecessary burden on travelers, [general practitioners] and the TGA, which was not justified by the extremely low risk these types of treatments present,” the administration wrote in a notice to disclose the new rules.
After consulting with bodies including the Australian Medical Association and Royal Australian College of General Practitioners, TGA has decided to allow travelers to bring up to a three-month supply of their medicines into Australia.
Pakistan outlines steps for testing diethylene glycol, ethylene glycol for contamination
The Drug Regulatory Authority of Pakistan (DRAP) has outlined how companies that use diethylene glycol and ethylene glycol in oral formulations can get the solvents tested for contaminants by the Central Drug Testing Laboratory (CDL) in Karachi.
Concerns about the contamination of the solvents have intensified in the wake of deaths linked to cough syrups in Gambia and Indonesia. The CDL in Karachi has responded to the public health threat by offering to test diethylene glycol and ethylene glycol and publishing guidance on how companies can access the service.
The guidance features instructions on sampling the solvents and how to pay the Rs 23,000 ($100) fee for the testing of each batch. Companies need to submit materials including a sampling information sheet, certificate of analysis by the manufacturer and testing request letter, plus three 30ml bottles of the materials to be tested.
The CDL will test the samples on a first in, first out basis and has not provided a target for how long it will take to perform the work and provide results.
India calls for medical device testing laboratories to step up to increase assessment capacity
CDSCO has asked accredited Indian laboratories that have capacity to test medical devices to apply to assess products under the Medical Devices Rules (MDR), 2017.
To date, Indian authorities have registered 28 laboratories for assessing medical devices under MDR, 2017, a law that imposed new requirements on the medtech industry. However, like their counterparts in the European Union, Indian officials see a need to add more testing capacity to cope with the demands created by the legislation.
To address that need, CDSCO has put out a request to laboratories that are accredited by the National Accreditation Board for Testing and Calibration Laboratories and have capacity to take on medical device work. The regulator wants laboratories that meet those criteria to submit MDR, 2017 applications.
TGA has issued a Serious Scarcity Substitution Instrument (SSSI) to address a shortage of the antibiotic cephalexin. The SSSI empowers pharmacists to provide another cephalexin medicine when the prescribed medicine is unavailable without prior approval from the prescriber. Cefalexin 250 mg capsules are not scarce in Australia. TGA Notice
India’s National Pharmaceutical Pricing Authority (NPPA) has again extended the deadline for submitting certain drug and medical device pricing information. Typically, NPPA wants information within 15 days of the end of the quarter. However, the authority delayed the deadline for the quarter ending in September to the end of 2022 in October and has now pushed it back again to 15 February. NPPA Notice