Asia-Pacific Roundup: New Zealand pushes ahead with GMP changes
Roundups | 13 April 2021 |
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is going ahead with its planned changes to good manufacturing practices (GMPs) after receiving largely positive feedback to a consultation.
In February, Medsafe began gathering views on its plans to adopt the updated PIC/S Guide to GMP. The change would replace a GMP code from 2009 with a version adopted by PIC/S, the Pharmaceutical Inspection Co-operation Scheme, in 2018. Doing so will bring significant changes to how Medsafe approaches topics including cross-contamination and starting materials, according to the agency.
Medsafe received feedback from five respondents. Four agreed with Medsafe’s proposed timing of the transition to the new rules, which would see the updated GMP code take effect on 3 May and give the industry until 3 November to fully adapt to the revised rules. The fifth respondent called for more time to implement the updated code.
Over the past two years, Medsafe has made manufacturers aware of its intention to adopt the new rules, the agency said, and during audits has encouraged companies to review the old code against the updated PIC/S Guide to GMP. Other regulatory agencies, notably Australia’s Therapeutic Goods Administration (TGA), have already switched to the updated guide.
The overall feedback to the consultation was “generally positive,” Medsafe said. One respondent asked for additional guidance on how to interpret the requirements for GMP manufacture of aseptically compounded medicines under a “Licensed to Manufacture.” Medsafe also fielded requests for further information on “some specific clauses which affect individual responders.” The agency will contact respondents by phone or email to discuss their requests.
Medsafe Notice
In May, remdesivir’s developer, Gilead Sciences, granted royalty-free licenses to Cipla, Hetero Drugs, Jubilant Life Sciences, Mylan and Ferozsons. Multiple manufacturers now are serving the Indian market yet supplies are not adequate for the current wave of COVID-19 cases.
Last week, CDSCO asked its regional officials to “initiate remedial action” to ensure the supply of the antiviral. The request followed reports of shortages in several states that CDSCO warned could lead to “hoarding and black marketing.”
Days later, CDSCO issued a second notice describing reports of overcharging and asking its employees to “verify stocks and check other malpractices” while also taking “other effective action to curb hoarding and black marketing. CDSCO wants staff to immediately step up their oversight and take “stringent action” against anyone found to be hoarding or overcharging for remdesivir.
The request took place against a backdrop of soaring COVID-19 cases in India. The seven-day average of confirmed cases rose from around 11,000 in mid-February to 134,000 in mid-April. The number of deaths underwent a similar rise, although at the time of writing the seven-day average is still well below the September peak.
CDSCO Notice, More
In 2019, TGA published guidance on advertising for businesses involved with stem cells and other HCT therapies, specifying that advertising most HCT products to the public is prohibited. The annual report of TGA’s advertising enforcement operation for the 2019 to 2020 financial year has little evidence of noncompliance by businesses involved with HCT therapies.
Still, the agency is concerned that patients who have tried conventional treatments without success are “especially vulnerable to claims about emerging treatments not included in the Australian Register of Therapeutic Goods,” adding that their situation “may impact on their ability to critically evaluate whether a particular good is appropriate.”
The vulnerability of the patient population supports criminal offences and civil penalties for people who breach the advertising rules. TGA said the offences and penalties can apply to autologous HCT therapies that are exempt or excluded from being included in the Register.
TGA Notice
In January, FDA posted a circular regarding the implementation of guidelines on the authorization of devices under the Association of Southeast Asian Nations harmonized technical requirements. The text set out requirements for the issuance of a Certificate of Medical Device Notification (CMDN) but lacked some details.
FDA said the circular “does not specify provisions for the period wherein the companies may be allowed to manufacture, import, export, distribute, sell and/or offer for sale their medical device products covered under the said issuance without the CMDN.”
The new draft guidelines address that gap by providing advice on a transition period, during which the medical device industry can apply for CMDNs and make, trade and sell their products pending the issuance of the notification. FDA will allow businesses with a Licence to Operate to continue their activities without a CMDN until the end of March 2022. Beyond that, companies will need a CMDN or a pending application to trade.
FDA Notice
Under the revised rules, companies need to obtain approval for press releases about the launches of medical devices. Companies can continue to publish advertorials and run disease awareness and health education campaigns without seeking approval, provided the materials comply with the rules set out in both the old and updated guidelines.
Elsewhere, MDA used the update to revise its position on standards of promotion and device claims. The revised standards section features new text explaining that adverts “shall contain information that is reliable, accurate, truthful, informative, fair, objective, unambiguous, balanced, up-to-date and be capable of substantiation.” MDA also added language prohibiting misleading statements or visuals that may “abuse the trust or exploit the lack of knowledge among the general public.”
The application guidance, which used to be part of the broader advertising document, now features a section on conditions for application that explains companies can seek approval for adverts that use the same content across multiple languages in a single submission. Multiple applications are needed if the advert contains sound or video recordings for use on TV, radio and the internet.
MDA Guidance, More
In February, Medsafe began gathering views on its plans to adopt the updated PIC/S Guide to GMP. The change would replace a GMP code from 2009 with a version adopted by PIC/S, the Pharmaceutical Inspection Co-operation Scheme, in 2018. Doing so will bring significant changes to how Medsafe approaches topics including cross-contamination and starting materials, according to the agency.
Medsafe received feedback from five respondents. Four agreed with Medsafe’s proposed timing of the transition to the new rules, which would see the updated GMP code take effect on 3 May and give the industry until 3 November to fully adapt to the revised rules. The fifth respondent called for more time to implement the updated code.
Over the past two years, Medsafe has made manufacturers aware of its intention to adopt the new rules, the agency said, and during audits has encouraged companies to review the old code against the updated PIC/S Guide to GMP. Other regulatory agencies, notably Australia’s Therapeutic Goods Administration (TGA), have already switched to the updated guide.
The overall feedback to the consultation was “generally positive,” Medsafe said. One respondent asked for additional guidance on how to interpret the requirements for GMP manufacture of aseptically compounded medicines under a “Licensed to Manufacture.” Medsafe also fielded requests for further information on “some specific clauses which affect individual responders.” The agency will contact respondents by phone or email to discuss their requests.
Medsafe Notice
CDSCO warns of remdesivir hoarding as COVID cases soar in India
India’s Central Drugs Standard Control Organization (CDSCO) has told its staff to “take stringent action” to stop the hoarding of the COVID-19 antiviral remdesivir. CDSCO issued the notice after receiving reports of overcharging and black-market activities that have seen the drug sell for 10 times its maximum retail price.In May, remdesivir’s developer, Gilead Sciences, granted royalty-free licenses to Cipla, Hetero Drugs, Jubilant Life Sciences, Mylan and Ferozsons. Multiple manufacturers now are serving the Indian market yet supplies are not adequate for the current wave of COVID-19 cases.
Last week, CDSCO asked its regional officials to “initiate remedial action” to ensure the supply of the antiviral. The request followed reports of shortages in several states that CDSCO warned could lead to “hoarding and black marketing.”
Days later, CDSCO issued a second notice describing reports of overcharging and asking its employees to “verify stocks and check other malpractices” while also taking “other effective action to curb hoarding and black marketing. CDSCO wants staff to immediately step up their oversight and take “stringent action” against anyone found to be hoarding or overcharging for remdesivir.
The request took place against a backdrop of soaring COVID-19 cases in India. The seven-day average of confirmed cases rose from around 11,000 in mid-February to 134,000 in mid-April. The number of deaths underwent a similar rise, although at the time of writing the seven-day average is still well below the September peak.
CDSCO Notice, More
TGA reviews stem cell advertising
TGA is investigating the advertising of stem cell therapies to ensure compliance with the Australian rules on the promotion of therapeutic goods, asking consumers who see adverts for stem cell or autologous human cell and tissue (HCT) therapies to submit a report.In 2019, TGA published guidance on advertising for businesses involved with stem cells and other HCT therapies, specifying that advertising most HCT products to the public is prohibited. The annual report of TGA’s advertising enforcement operation for the 2019 to 2020 financial year has little evidence of noncompliance by businesses involved with HCT therapies.
Still, the agency is concerned that patients who have tried conventional treatments without success are “especially vulnerable to claims about emerging treatments not included in the Australian Register of Therapeutic Goods,” adding that their situation “may impact on their ability to critically evaluate whether a particular good is appropriate.”
The vulnerability of the patient population supports criminal offences and civil penalties for people who breach the advertising rules. TGA said the offences and penalties can apply to autologous HCT therapies that are exempt or excluded from being included in the Register.
TGA Notice
Philippine FDA seeks feedback on transition to new medical device rules
The Philippine Food and Drug Administration (FDA) is seeking feedback on its transition to incoming medical device rules.In January, FDA posted a circular regarding the implementation of guidelines on the authorization of devices under the Association of Southeast Asian Nations harmonized technical requirements. The text set out requirements for the issuance of a Certificate of Medical Device Notification (CMDN) but lacked some details.
FDA said the circular “does not specify provisions for the period wherein the companies may be allowed to manufacture, import, export, distribute, sell and/or offer for sale their medical device products covered under the said issuance without the CMDN.”
The new draft guidelines address that gap by providing advice on a transition period, during which the medical device industry can apply for CMDNs and make, trade and sell their products pending the issuance of the notification. FDA will allow businesses with a Licence to Operate to continue their activities without a CMDN until the end of March 2022. Beyond that, companies will need a CMDN or a pending application to trade.
FDA Notice
MDA updates guidance on advertising medical devices in Malaysia
Malaysia’s Medical Device Authority (MDA) has updated its guidance on advertising medical devices, separating the section on applying for approval of a medical device advertisement off into a different document and tweaking aspects of the remaining text.Under the revised rules, companies need to obtain approval for press releases about the launches of medical devices. Companies can continue to publish advertorials and run disease awareness and health education campaigns without seeking approval, provided the materials comply with the rules set out in both the old and updated guidelines.
Elsewhere, MDA used the update to revise its position on standards of promotion and device claims. The revised standards section features new text explaining that adverts “shall contain information that is reliable, accurate, truthful, informative, fair, objective, unambiguous, balanced, up-to-date and be capable of substantiation.” MDA also added language prohibiting misleading statements or visuals that may “abuse the trust or exploit the lack of knowledge among the general public.”
The application guidance, which used to be part of the broader advertising document, now features a section on conditions for application that explains companies can seek approval for adverts that use the same content across multiple languages in a single submission. Multiple applications are needed if the advert contains sound or video recordings for use on TV, radio and the internet.
MDA Guidance, More
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