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ACSS - NAS work sharing initiative

Australia-Canada-Singapore-Switzerland (ACSS) Consortium

11 September 2019
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ACSS background

The ACSS Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia's Therapeutic Goods Administration (TGA), Health Canada (HC), Singapore's Health Sciences Authority (HSA) and the Swiss Agency for Therapeutic Products (Swissmedic). Regulatory authorities face very similar challenges, such as increasing workload and increasing complexities in the medicinal applications that are being regulated, thus contributing to increasing pressure on available resources. The purpose of the consortium is to build synergies and share knowledge amongst the regulatory authorities thereby enhancing efficiency of regulatory systems.

The ACSS Consortium consists of various projects that aim to help meet the challenges faced by regulatory authorities, including timely access to safe therapeutic products within a limited resource capacity. The ACSS uses a network of bilateral confidentiality agreements and Memoranda of Understanding to conduct their work.

ACSS NAS work-sharing pilot

The New Active Substance (NAS) working sharing initiative (previously known as New Chemical Entity working group) was established to focus on developing opportunities within a regulatory program through the greater alignment of regulatory approaches and technical requirements. With this in mind, the NAS work sharing initiative launched an innovative pilot for the coordinated assessment of NAS applications that had been filed within two jurisdictions.

Initially, the ACSS NAS work sharing initiative focused on common submissions between Health Canada and Therapeutic Goods Administration. Once a candidate was identified, a pilot NAS working sharing initiative was developed which built confidence in the concept. During the pilot, each regulator evaluated their respective Module 1; Health Canada evaluated Module 3 (Quality) and TGA evaluated Module 4 (Non-clinical), with both regulators separately evaluated Module 5 (Clinical). Through this pilot a framework to navigate the practicalities of undertaking a coordinated assessment was established, that complemented the regulatory decision-making within each jurisdiction.

The work-sharing pilot demonstrated a truly unique global collaboration between regulatory authorities and the pharmaceutical industry. The valuable knowledge and experience obtained through this pilot exercise informed internal procedures on the effective use of international assessment reports. This further supported the benefits for the pharmaceutical industry, that included a reduction in regulatory burden (e.g., with the filing of common dossiers), consolidated information requests, timely regulatory decisions, concurrent market authorisation decisions, and the opportunity to contribute to advancing regulatory innovation.

Next steps

ACSS consortium NAS work sharing initiative is actively exploring opportunities for work-sharing with industry, and is seeking applications for this initiative via the downloadable 'Expression of Interest' form. To be a suitable candidate for this work-sharing initiative, applications should be submitted simultaneously to at least two of the ACSS Consortium members.

It is preferable that Modules 2-5 of the application contain common information. However, any differences in Modules 2-5 should be clearly identified by the applicant (e.g., using the template provided within the Expression of Interest form for summarizing any differences). In addition, the application submitted to each of the identified regulatory authorities would include the country-specific Module 1 for the respective agency.

Interested applicants are invited to participate in this innovative work by contacting your regional regulatory authority:

Communications via email should include 'ACSS Consortium - NAS work sharing' in the subject line.

Q&A

Useful links

How to access a Word document

Contact information

Email: streamlinedsubmission@health.gov.au

Email subject line should contain 'ACSS Consortium - NAS work sharing'

This image demonstrates an example of the possible division of labour for a working-sharing submission. Here, an identical dossier is used across all jurisdictions and each agency is allocated a module(s) to evaluate. The information from the evaluation process is shared between the partners, and this allows each partner to make their own sovereign decision regarding the approval of the medicine to market.
  • Identical dossiers across jurisdictions (noting country-specific aspects)
  • Lead time of 3-6 months to filing date to facilitate planning
  • Same pathway across jurisdictions (standard-only or priority-only, NOT a mixture of standard/priority pathways)
  • Agreement from all regulators involved for work-share model
  • Independent decision-making by each jurisdiction

Evaluation plan:

  • adopts TGA milestone system; tailored to each submission through negotiation
  • includes time for intra- and inter-agency peer review (PR) and evaluator
  • national steps = expert advice, labelling/PI, decision
This image depicts the key milestones in a standard work-sharing application. The timeframes for these milestones can vary, and this is dependent on the type of application and the prior negotiations that take place between the sponsor and ACSS partners.

Country-specific evaluation:

  • national guidelines
  • Module 1 (PI, CMI, labels, GMP)
  • Module 3: TGO's, stability
  • Module 4: pregnancy category
  • RMP
  • Wording of indications

Division of evaluation labour:

  • Module 3 (± BE)
  • Module 4 (+ impurities consult)
  • Module 5 (± popPK, clinical pharmacology)

FACILITATING ACSS WORK SHARING FOR NEW CHEMICAL AND BIOLOGICAL ENTITIES

Building on the experience of international work sharing pilots under the Australia Canada Singapore Switzerland (ACSS) Consortium, this document outlines key information for industry in filing an international work sharing submission. ACSS work sharing offers sponsors:

  • Streamlined process - internationally coordinated review to reduce duplication and burden
  • Increased Access - possibility of simultaneous access to markets of multiple countries
  • Flexibility - adaptability in how regulators organize collaboration amongst each other on a given review and which countries a company chooses to submit applications
  • Predictability - pre-determined milestones and targeted review timeframes

Pathways

New drug submissions filed with two or more partner regulators for a new chemical or biological entity.

Two potential pathways, upon agreement of all partner regulators, to which a submission was filed:

  1. Standard
  2. Priority (expedited, e.g., for drugs with an unmet medical need)[1]

Guidance for Industry

  1. Advance Notice: Early interactions with regulators are important for assessing whether work sharing is a feasible option, and for assisting with alignment and planning discussions.
    • Industry is invited to submit an Expression of Interest (EOI) at least 3 months before the intended filing date.
    • If possible however, sponsors should provide the EOI up to 6 months in advance, in particular for a priority review submission or when seeking a technical pre-submission meeting.
  2. Coordinated Filing: Sponsors are required to file separate applications to each regulator where a market authorization is intended:
    • independently within a two-week window of each other[2]; and
    • to the same pathway (i.e., standard or priority[3]) across all partner regulators.
  3. Consistency in Submission Information Provided: The content of submissions across partner regulators should be consistent, with the exception of select nation-specific application requirements which should be noted in the EOI. A sponsor seeking consideration for a priority review will need to indicate that interest when filing the EOI with each partner regulator[1].

Regulatory Commitments

  1. Predictability and transparency: Regulators will provide clarity to the Sponsor on the work sharing approach and establish key milestones at the earliest opportunity. Sponsors will be informed (normally within 6 weeks) of the potential for work sharing prior to the filing of the dossier. Partner regulators will identify the following: the lead regulator; project milestones; review stream leads; and model of collaboration deemed appropriate for the submission.
  2. Coordinated approach - Sponsors can expect coordinated key communications from regulators. Partner regulators will have protocols for when, and in what form, key communications would be transmitted to sponsors and/or the public across regulators (e.g., clarification requests, announcements of positive decisions or approvals).
  3. Sovereign Decisions: Countries will maintain sovereign decision-making. Some specific areas where national decision-making procedures should be noted: i) determination/designation of a submission under the "priority" pathway; ii) acceptance at the validation/screening stage; iii) approval or rejection of market authorization; and iv) labelling content (e.g., indication), if approved. Regulators will aim to issue their sovereign decisions within agreed to timelines.

Footnotes