Regulatory Focus™ > News Articles > 2022 > 5 > Asia-Pacific Roundup: New Zealand’s Medsafe tweaks fee increase proposal after industry feedback

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Posted 17 May 2022 | By Nick Paul Taylor 

Asia-Pacific Roundup: New Zealand’s Medsafe tweaks fee increase proposal after industry feedback

2941 The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised its upcoming fee changes in light of industry feedback on the draft proposal. Medsafe is retaining the proposed 4.2% increase across all fees but making several changes to specific elements of the schedule.
 
Last year, Medsafe released a set of proposed fee increases for consultation. The regulator determined the fees using the Treasury’s charging guidelines for cost recovery and asked affected stakeholders for responses to 15 questions. The consultation drew 31 responses, mainly from pharma companies and trade groups that represent them, and revealed resistance to some of the proposed changes.
 
Some respondents pushed back against Medsafe’s plan for automatic referral of some changed medicine notifications (CMNs) under section 24(5) of the Act. Respondents warned the proposal does not support the ongoing registration of some generic medicines leading to product rationalization, would cut access to medicines for New Zealanders and discourage sponsors from submitting applications to extend or add new indications.
 
Medsafe partly held its ground, arguing that most CMNs referred under section 24(5) need substantially more resources than is reflected in their current fee of NZ$3,200 ($2,025). As Medsafe wants to align fees with the time spent on evaluation of medicine applications, the regulator is pushing ahead with its plan to raise the price of CMNs referred under section 24(5), but it is limiting the scope of the automatic renewal initiative and reducing the fee increase.
 
Respondents also warned that, “Proposed increases to provisional consent fees were too high and would discourage applications,” adding that the changes to the rates for out-of-stock situations “could lead to sponsors being reluctant to submit applications due to cost, instead relying on supply of unapproved medicines under section 29 of the Medicines Act.” Some respondents called for the Ministry of Health or the Pharmaceutical Management Agency to cover or subsidize fees.
 
Again, Medsafe defended the motivation of the proposal while acquiescing to calls for some changes to the details. The proposed fee structure was designed to “ensure consistency between costs of section 20 (full consent) medicine applications and section 23 (provisional consent) applications that are later converted to full consent,” Medsafe said.
 
Yet, Medsafe also accepted that there “is a necessary balance between encouraging participation in the regulatory system, and of ensuring that cost recovery is based on evaluation effort.” The feedback led Medsafe to revise its fees. Medsafe reduced the fee for provisional consent due to clinical need from 80% to 66% of the risk category.
 
 
Other changes include the trialing of an administrative cap of four self-assessable change notification (SACN) category fees for each assessable or nonassessable submission. Medsafe agreed to trial the new approach after respondents felt it was reasonable to charge a fee for SACNs when submitted with a CMN but questioned the imposition of the full NZ$415 administrative fee and the fee for multiple names, strengths and dosage forms. Medsafe will reconsider its options if the trial fees fail to cover its costs.
 
Review Outcome
 
Philippine FDA seeks feedback on medical device storage and distribution practices
 
The Philippine Food and Drug Administration (FDA) has released draft medical device good storage and distribution practices for consultation. FDA has created the draft to ensure the quality of medical devices is maintained throughout the supply chain.
 
In setting out the need for guidance, FDA states, “It is essential that establishments ensure that medical devices are protected from various risks that will adversely affect the quality of these products during the various stages in the supply chain.” That thinking led the Philippine Department of Health to publish an administrative order requiring the “appropriate storage condition to maintain the safety and quality of health products” in 2020.
 
FDA’s draft guidance expands on the administrative order to cover delivery, transportation, installation, servicing and maintenance, as well as storage. The FDA draft therefore applies to manufacturers, traders, exporters, importers, wholesalers and retailers of medical devices.
 
Under the terms of the guidance, companies that handle medical devices must keep purchase and sale records that include details such as the date of the transaction, lot number and expiration date. Some of the requirements are specific to certain stakeholders. FDA wants all stakeholders to retain the records for as long as the medical device product is registered. The records should “show traceability of the origin.”
 
The draft also proposes standard operating procedures that companies should have and requirements for their personnel and premises. FDA wants companies covered by the guidance to store their medical devices in an area that is “designed and equipped to prevent entry of vermin and other animals” and to have “a written vermin control program.”
 
FDA is accepting feedback on the draft until 11 June. 
 
FDA Consultation
 
TGA lifts age limit on Sinopharm COVID-19 vaccine, starts review of Moderna shot
 
Australia’s Therapeutic Goods Administration (TGA) has removed the age limit on the use of Sinopharm’s BBIBP-CorV COVID-19 vaccine for meeting the requirements of international travel to Australia.
 
Originally, TGA only allowed people under the age of 60 to use proof of vaccination with BBIBP-CorV to meet the entry requirements for international travelers. The vaccine is not authorized for use in Australia but TGA has recognized it, along with other COVID-19 shots, for the purposes of international travel to enable more people to enter the country.
 
TGA decided to allow older people to use BBIBP-CorV as proof of vaccination after reviewing the findings of five recent studies, including one in subjects over 60 years of age, that suggest the vaccine is more efficacious than previously thought. TGA also cited “the change in the overall risk of progression to severe disease from COVID-19 in older people with the emergence of the omicron strain of the virus.”
 
The agency shared details of the change on the same day as it disclosed the initiation of a review of Moderna’s Spikevax COVID-19 vaccine in children aged six months to five years old. The vaccine is currently authorized for use in children aged six years and up.
 
TGA Notice, More
 
Pakistan’s DRAP finalizes guidance on clinical trial submissions and pharmacovigilance
 
The Drug Regulatory Authority of Pakistan (DRAP) has finalized its guidance on making applications for clinical trials and the promotion of pharmacovigilance activities by public health programs.
 
DRAP released draft versions of the two documents for consultation last month. The clinical trial text is almost identical to the draft version. DRAP has updated a reference to clarify that its reference to the International Council for Harmonisation good clinical practice guidelines refers to E6, removed text about the document being a draft and added an effective date for the final document of May 20.
 
The final pharmacovigilance test also hews very closely to the draft released for consultation in April. DRAP has changed the heading of one section from “glossary” to “definitions and acronyms” but the rest of the text is largely unchanged from the draft. The pharmacovigilance guidance will take effect on May 25. 
 
DRAP Guidance, More
 
Other News:
 
The Philippine FDA has granted emergency use authorization to Sinovac’s CoronaVac COVID-19 vaccine in people aged six to 17 years old. FDA Notice

 

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