Asia Regulatory Roundup: TGA Details How Manufacturers Can Seek GMP Clearance Prioritization

RoundupsRoundups | 02 July 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Details How Manufacturers Can Seek GMP Clearance Prioritization
Australia’s Therapeutic Goods Administration (TGA) has provided guidance on how manufacturers can request the prioritization of their good manufacturing practice (GMP) clearance requests.
In recent years, the sharp increase in the number of requests to TGA to establish the compliance of overseas manufacturing plants has created a backlog at the agency. TGA has made multiple changes intended to help get on top of the problem, but it is still taking longer to process applications than in the past. Last month, TGA set the target processing timeline for compliance verification of sterile or biotech finished products at 120 days.
The lengthening of processing times has raised the risk that manufacturers will submit applications too late to guarantee that they will receive clearance in time to meet their regulatory obligations. In general, TGA will not fast-track applications from companies in this situation, arguing that they should plan their regulatory activities around its processing times.
However, in some circumstances, such as when a late application could lead to a drug shortage, TGA will consider requests for priority assessment. TGA set out its views on the topic in an update to its GMP clearance guidance.
The guidance details TGA’s reluctance to prioritize applications before outlining what companies should do if they think they warrant such special treatment. TGA wants applicants seeking priority assessment to “provide the appropriate level of detail and justification upfront via a cover letter.”
If the request relates to the potential for a late application to result in a drug shortage, TGA expects the manufacturer to provide details “surrounding the reporting of that shortage to the Medicines Shortages area,” plus other relevant information such as the level of existing stock on hand.
The addition of the section on prioritization requests is the most notable change to the guidance. TGA also used the update to add target processing timelines for compliance verification to the text, but had previously disclosed those details in a separate release last month.
TGA Guidance
India Proposes Making Marketers Responsible for Drug Product Quality
The Indian health ministry is planning to make marketers responsible for the quality of the medicines they sell.
Under the Drugs and Cosmetics Rules, manufacturers are liable for the quality of medicines sold in India. The current system means a marketer can source a drug from a third-party manufacturer and put it on the market without being responsible for the quality of the product. If adopted, the revision proposed this week would change that.
“Any marketer who sells or distributes any drug shall be responsible for quality of that drug as well as other regulatory compliances along with the manufacturer under these rules,” the draft proposal states.
Business Standard, quoting an anonymous senior government official, reported that the amendment is intended to stop larger pharmaceutical companies from pinning the blame on smaller contract manufacturers when their products are found to be substandard.
The proposal was welcomed by the Organisation of Pharmaceutical Producers of India, which said the change is in line with its belief that, “Quality should be embedded in every stage of the medicine-making process and across the delivery chain.”
The draft is open for comment for 30 days.
Draft Proposal, Business Standard
TGA Revises Guidelines on Regulatory Exclusion of Cell and Tissue Products
TGA has updated its guidance for manufacturers of autologous human cells and tissues (HCT) products. The changes give manufacturers the option to perform storage and testing outside hospitals while remaining exempt from TGA regulation.
When TGA adopted the guidance 12 months ago, it stated HCT products are only exempt from its regulations if they are manufactured at a medical or dental practitioner, or people under their supervision, at the hospital where they will be administered. Now, TGA has slightly relaxed that requirement to permit some activities to take place outside the hospital setting.
TGA still expects “generally all steps of manufacturing” to occur within the hospital, but will now permit third-party storage and testing to take place off site. The change reflects the fact that some hospitals lack the capacity to perform some work internally.
In justifying the change, TGA described the revised rule as consistent with current practices whereby hospitals enlist specialist service providers to perform tests not offered by their in-house pathology providers. Similarly, hospitals already contract with storage providers for non-HCT product materials to overcome their internal space constraints.
The revised rules permit hospitals to enter into similar arrangements for HCT products. The only caveat applied by TGA is that the contract must be between the service provider and the hospital, not the individual practitioner.
TGA Guidance
New Zealand Floats Plan to Mandate Inclusion of Allergens on Drug Labels
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is seeking feedback on plans to make manufacturers list allergens on drug product labels. Medsafe is considering mandating the disclosure of 29 ingredients on drug labels from 1 September 2020 onward.
While manufacturers of food products sold in New Zealand have to disclose all ingredients on labels, the rules for drugmakers are looser. Medicine producers need to list the active ingredient but are not required to disclose all excipients or impurities from manufacturing, even if the substances can cause allergic reactions.
To mitigate the risk of allergic reactions, Medsafe is proposing to tighten up the rules. The agency is considering making manufacturers disclose the presence of 27 ingredients, including egg, gluten and lactose for the first time. Medsafe is also proposing changing the rules regarding two ingredients that are already included in the Label Statements Database.
Before making the changes, Medsafe wants to learn what the industry thinks of the proposal. The feedback form details the statement about each ingredient that Medsafe is planning to make mandatory and asks whether the respondent agrees with the proposal and the conditions attached to it. Medsafe also wants to gather views on the proposed implementation date.
Medsafe is accepting feedback on the proposals until 8 August.
Medsafe Consultation
Medsafe Updates Notification Form for Biological Changes After Consultation
Medsafe has updated the form manufacturers use to notify it of material changes to biologicals and other biotechnology products. The finalization of the changes follows a consultation that attracted responses from companies including GlaxoSmithKline and Merck.
Collectively, the six respondents to the 2018 consultation on CMM Form B provided feedback that led Medsafe to clarify and revise its position. Changes made by Medsafe in response to the feedback include the alignment of a fee with other similar categories and the revision of criteria to permit the use of self-assessable change notifications when tightening specification limits for some excipients. 
Respondents including Merck asked Medsafe to consolidate CMN Form A, which is used to notify the agency of changes to other types of product, and CMN Form B. Merck argued the documents could be “combined into a single dual-purpose form” as they “share a significant number of change types.” Medsafe referred to the request in its summary of the feedback but did not respond fully to it as it was outside the scope of the consultation.
Medsafe adopted the revised form on 1 July. All CMN Form B submissions from now on should use the revised document.
Medsafe Notice


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