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Regulatory Focus™ > News Articles > 2022 > 2 > Asia-Pacific Roundup: Years after EMA action, Malaysia rejects BE studies over GCP issues

Asia-Pacific Roundup: Years after EMA action, Malaysia rejects BE studies over GCP issues

Posted 08 February 2022 | By Nick Paul Taylor 

Asia-Pacific Roundup: Years after EMA action, Malaysia rejects BE studies over GCP issues

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has rejected bioequivalence studies done at two facilities run by Micro Therapeutic Research Labs in India. The action comes five years after the European Medicines Agency (EMA) warned pharmaceutical companies it would not accept results from studies performed at the two facilities in marketing authorization applications.
 
EMA issued its notice in March 2017. The notice followed a February 2016 inspection that resulted in observations of noncompliance with good clinical practices and data integrity issues at the two facilities. EMA responded to the compliance concerns by rejecting data from bioequivalence studies conducted at the two sites between June 2012 and June 2016, and by suspending the marketing authorizations of products that relied on data from the centers.
 
At a 10 January 2022 meeting of the Committee for Premises and Study Inspections, NPRA decided to reject bioequivalence studies from the two facilities. The action entails the “rejection of all application for the Evaluation on the Need for BE Study Inspection (BEDE) for BE studies conducted between June 2012 and June 2016.” Studies conducted from July 2016 are eligible for BEDE application. NPRA imposed a slightly different set of restrictions on submissions to its Centre of Product & Cosmetic Evaluation.
 
NPRA listed one of the affected Micro Therapeutic Research Labs sites among the centers in its national Bioequivalence Centre Compliance Programme in January 2019. The listing was valid until January 2022. NPRA last updated the list in November 2021.
 
The agency will enforce the decision reached at last month’s meeting with immediate effect.
 
NPRA Letter
 
India extends caps on trade margins of COVID-19 medical devices until July
 
India’s National Pharmaceutical Pricing Authority (NPPA) has extended the caps on the trade margins of five classes of medical devices deemed essential for the management of the COVID-19 pandemic until the end of July.
 
NPPA imposed the 70% trade margin cap on pulse oximeters, blood pressure monitoring machines, nebulizers, digital thermometers and glucometers in July. In doing so, NPPA affected the maximum retail price (MRP) of the devices. MRP is calculated using a formula based on the trade margin and price to the distributor.
 
The action followed the discovery of trade margins of up to 709% and a similar action involving oxygen concentrators that the Indian government said “resulted in significant savings to the consumer and rationalization in the price.”
 
NPPA originally planned to lift the cap on the trade margins of pulse oximeters and the other four types of devices at the end of last month. However, the price watchdog extended the provisions until 31 July on the day they were set to lapse. Late last year, India extended the 70% cap on the trade margins of oxygen concentrators until the end of May 2022.
 
Government Notice
 
Malaysia’s MDA publishes guidance on refurbished medical devices
 
Malaysia’s Medical Device Authority (MDA) has released guidance to help manufacturers and authorized representatives submit notifications about refurbished medical devices. MDA has made major changes to the text since releasing a draft version for consultation in 2020.
 
The final guidance features new definitions of terms such as refurbisher, remanufacturing, maintenance, third-party refurbisher and used medical device. MDA has retained the definition of refurbished medical device. The definition covers products that have wholly or partly been rebuilt to create devices with the same intended purpose as the original products.
 
MDA has changed most of the rest of the text. The final guidance sets out two routes to market for refurbished medical devices, each of which has its own requirements. One route is open to devices that are refurbished by the manufacturer.
 
The other route is for devices that are refurbished by a third party, defined in the guidance as any person authorized by the manufacturer to refurbish a medical device, and placed on the market under its own name. Third-party refurbishers that place refurbished medical devices on the market under their own names are considered to be a manufacturer as defined by Malaysia’s Medical Device Act 2012.
 
MDA Guidance
 
Philippine FDA seeks feedback on transition to new COVID-19 test requirements
 
The Philippine Food and Drug Administration (FDA) is holding a consultation into the planned transition to new technical requirements for the registration of COVID-19 tests.
 
Early in the pandemic, FDA added COVID-19 tests to the list of in vitro diagnostics it must authorize before they are imported, distributed or sold in the Philippines. Given the limited clinical data available at the time on COVID-19 tests, FDA allowed products to come to market on the strength of just “limited documents.” The situation has changed since then, driving FDA to reconsider its evidence requirements.
 
“Considering that developments have been made in establishing clinical data for COVID-19 test kits and there is already adequate supply of these products in the market, it is prudent to require compliance of these products to the FDA technical requirements for product registration similar with other regulated IVDs to ensure their quality, safety and performance,” FDA wrote in its draft proposal.
 
The proposal features a planned transition from the Special Certification issued under the outgoing rules to the Certificate of Product Registration (CPR) that will be needed going forward. Manufacturers of tests with valid Special Certification when the proposal takes effect will need to apply for CPR. FDA will accept filings six months before the expiration of the Special Certification.
 
FDA is accepting feedback until 4 March.
 
FDA Notice
 
Pakistan threatens legal action against hoarders amid paracetamol supply issues
 
The Drug Regulatory Authority of Pakistan (DRAP) has threatened to take legal action against any group found to be hoarding paracetamol. DRAP’s warning follows disruption to the supply of the medicine.
 
According to DRAP, the availability of paracetamol is currently under pressure because of “higher than usual demand” and international disruption to the supply of the medicine’s active ingredient. The supply of paracetamol is disrupted in other countries, too, with the United Kingdom issuing a Serious Shortage Protocol late last month that covered two doses of the medicine.
 
DRAP said availability in Pakistan is lower than normal despite the leading paracetamol manufacturer increasing production by 13%. The supply of raw material is expected to improve “in a couple of weeks,” DRAP said, but for now the agency is seeking to manage the situation by preventing stockpiling.
 
“Consumers are requested to avoid overstocking medicines at their homes,” the agency said. “DRAP has also warned pharmacies, medical stores and wholesale distributors on stockpiling of drugs at this critical moment. Any attempt at hoarding of drugs is a punishable offense and legal action will be taken against perpetrators.”
 
DRAP Notice
 
Other News:
 
TGA has approved provisional determination for Gilead Sciences’ COVID-19 antiviral Veklury in children and adults who are at risk of progressing to severe disease. The determination clears Gilead to file to expand the Australian label of the antiviral, which currently covers its use in adults and adolescent patients with severe COVID-19 symptoms who have been hospitalized and require oxygen. TGA Notice
 
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has provisionally approved Novavax’s Nuvaxovid COVID-19 vaccine for use in adults. New Zealand has an agreement to buy almost 11 million doses from Novavax, but it is unclear if the government will follow up the Medsafe action with a decision to use the vaccine. Press Release

 

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