Asia-Pacific Roundup: Malaysia publishes guidance on manufacturing cell and gene therapies

RoundupsRoundups | 13 July 2021 |  By 

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has released guidance about cell and gene therapy manufacturing facilities. The guidance describes the process for setting up a facility in Malaysia and the local and international regulations and guidelines that cover the production of cell and gene therapies.
NPRA has provided a step-by-step guide to the regulatory side of setting up a facility to manufacture higher-risk cell and gene therapy products in Malaysia. The first step is to submit an application for the evaluation of the layout of the manufacturing plan along with the supporting documents and a processing fee. Manufacturers can only start setting up the pharmaceutical quality system (PQS) after receiving approval for the facility layout.
Preparation of the PQS is covered by guidelines such as the PIC/S Guide to Good Manufacturing Practice for Medicinal Products. NPRA will apply the guidelines to activities including construction of the manufacturing facility, the qualification of equipment and establishment of documentation about the training of personnel.
After completing the activities, NPRA expects manufacturers to apply to undergo a GMP inspection and make the required payment. Depending on the objective and product category, NPRA could put cell and gene therapy manufacturing facilities through pre-certification, pre-licensing, pre-approval, routine, verification or investigation inspections. NPRA will stop pre-certification inspections at the start of 2023.
GMP compliance status is valid for three years from the date of inspection. NPRA will subject cell and gene therapy facilities to routine inspections on a schedule dictated by their compliance status at the time of the previous assessment. During the pandemic, NPRA is conducting remote inspections that only grant GMP compliance status for two years.
NPRA Guidance
Philippine FDA extends cGMP clearances amid ongoing pandemic disruption
The Philippine Food and Drug Administration (FDA) has updated its guidance on the current good manufacturing practice (cGMP) clearances of foreign drug manufacturers in light of the ongoing COVID-19 pandemic.
FDA deferred all inspections of foreign drug manufacturing facilities until further notice in August. As FDA is unable to perform the overseas plant inspections required to issue cGMP clearances, the agency has extended the validity of existing authorizations of foreign manufacturers until the end of the year. The extension applies to all incoming and previously received renewal applications.
Manufacturers that apply to renew a cGMP clearance after 31 December will need to pay a penalty. The penalty is calculated by doubling the cGMP clearance fee and adding 10% a month for up to 120 days. FDA will consider applications filed after the 120-day period to be expired. Manufacturers with expired cGMP clearances will pay the total penalty plus the initial filing fee. The agency will put applications linked to expired clearances through the initial evaluation procedure and consider further regulatory actions.
The rest of the interim guidelines released by FDA describe the process for incoming applications to renew cGMP clearances. FDA expects manufacturers to follow the pandemic submission guidelines it set out last year and older documents that describe the required evidence for cGMP clearances. The list of acceptable supporting evidence includes a certificate of GMP compliance and a certificate of pharmaceutical product from the World Health Organization.
FDA’s interim guidelines will remain in place until the end of the year, unless they are revoked or extended before then.
FDA Notice
Japan adds myocarditis and pericarditis to caution about mRNA COVID-19 vaccines
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has added a cautionary statement about myocarditis and pericarditis to the labels of mRNA vaccines developed by Moderna and Pfizer.
PMDA is yet to receive reports of cases of myocarditis and pericarditis causally linked to the mRNA vaccines in Japan, where the government recently hit its goal of administering 1 million doses of the Moderna and Pfizer shots per day. However, reports of cases of myocarditis and pericarditis in other countries and the resulting regulatory actions overseas have persuaded PMDA to act.
The decision to change the package inserts is, in part, a reflection of evidence that prior instructions about vaccine side effects are critical to the early detection and prevention of potential adverse events. Once the recipients of vaccines know the symptoms to look out for, they may be more likely to identify signs of myocarditis and pericarditis and act accordingly.
PMDA also cited the anticipated increase in the vaccination of adolescents and young adults as a factor in the decision to add a statement about myocarditis and pericarditis. Most reported cases of myocarditis in the US have affected adolescents and young adults.
PMDA Summary
Australia plans changes to the visibility of suspended medical devices
Australia’s Therapeutic Goods Administration (TGA) has outlined planned changes to the visibility of suspended medical devices. TGA plans to hide suspended products from viewers of the Australian Register of Therapeutic Goods (ARTG).
Currently, TGA maintains a list of medical devices and in vitro diagnostics that are suspended from the ARTG. The list explains the grounds for a suspension and the dates it covers. However, other TGA resources do not reflect the suspensions, creating the potential for people to be given the impression that a suspended product can be lawfully supplied in Australia.
The planned changes target that risk of confusion. After the changes are implemented, suspended medical devices will no longer be visible on the ARTG. TGA will also put a “Suspended” watermark on the ARTG certificate and record summary for the affected product.
TGA suspended two medical devices from the ARTG last year. The end date for those actions passed in May. No medical devices have been suspended from the ARTG since November.
TGA Notice
TGA advises patients after volume of Philips recall calls causes difficulties
TGA has offered advice to patients who are struggling to get hold of Philips to discuss their concerns about the implications of its recall of sleep and respiratory devices. Philips has reportedly put extra resources in place to help manage the high volume of calls.
Earlier this month, Philips and TGA disclosed a recall of devices including continuous positive airway pressure (CPAP) products because of risks related to the degradation of sound abatement foam. The notice provided patients with a Philips phone number to call if they had questions or concerns after going over the recall information.
Days later, TGA issued an update after becoming “aware that some consumers are having difficulty contacting Philips about the safety concerns with their devices.” Philips told TGA it put additional resources in place to cope with the high level of concerns.
TGA is advising patients to register their devices on Philips’ website to help it create an approach to the repair or replacement of the products. In the meantime, TGA is “strongly” recommending that patients “do not attempt to remove the foam yourself and then continue using your device.” Youtube videos showing how to remove the foam have been viewed thousands of times.
TGA Notice
Other News:
The Central Drugs Standard Control Organisation (CDSCO) has finalized the Sugam module for online processing of written confirmation certificate applications required to import active substances into the European Union. CDSCO will stop accepting physical filings on 23 July. CDSCO Statement


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