Access New Active Substance and Biosimilar Work Sharing Initiatives

By engaging in these partnerships, Access is able to co-ordinate regulatory review procedures, and increase each agency’s capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products.

Assessment procedure

The Operational Procedures for the New Active Substance Work Sharing Initiative (NASWSI) (PDF, 419 KB, 13 pages) contains further details on this procedure.

The applicant should first express interest in the initiatives by using the NAS Expression of Interest (EOI) or Biosimilar Expression of Interest (EOI) form (MS Word Document, 177 KB) to the relevant authorities. This should be done 3 - 6 months before the target submission date.

The applicant must then submit identical dossiers (while taking country-specific aspects into account) to the relevant authorities participating in the work sharing initiative. Where possible, this should be done within a time frame of two weeks.

The application to the MHRA must be in eCTD format and in accordance with UK regulatory requirements. Modules 2-5 do not have to be identical across countries, but it is preferable that the same dossiers are submitted to all the participating regulators. Where there are differences, the ‘Summary of Differences between dossiers’ (included in the EOI form) should be completed outlining the differences in information provided to each regulator.

Each authority reviews the module or modules allocated to it for the main review. As soon as the main review of all modules is concluded, the evaluation reports will be shared via a secure IT platform. Modules will be peer reviewed by those participating authorities that have not conducted the initial main review. The authorities will then discuss the results in a teleconference and prepare a consolidated response to be communicated to the applicant.

Product labelling will not be part of the joint review process. There may be discussions among regulators about product labelling during the assessment phase, however regulators will review and determine this on a national basis, due to diverging regulatory and legal requirements.

Where the application is following the standard review pathway, clarification questions will be consolidated and sent to all local affiliates simultaneously. The timelines for this will be dependent on the milestones for the review agreed by the participating regulators. Questions specific to a given jurisdiction, such as those related to labelling, will be sent as needed and only to the local affiliate.

Where the application is following the priority review pathway (only applicable for the NAS work sharing initiative), any clarification questions that are raised during the assessment period will be sent to the respective local affiliate for a response. The clarification questions will also be shared with the partnering regulator and their local affiliate to allow for a subsequent eCTD sequence to be sent to ensure that the application is complete for all participating regulators.

It should be noted that the current MHRA biosimilar guideline is not applicable to other Access agencies. Each regulator will maintain its independence in making a final decision. Marketing authorisation approval or refusal by one regulator may therefore not affect the decision or the timing of the decision of the remaining participating regulators.

The decision date under the joint review will be provided in the evaluation timeline and is as agreed by the participating regulators and then communicated with the applicant. National procedures still apply for posting an external summary of the application e.g. UK Public Assessment Report (PAR), AusPAR, Canadian Summary Basis of Decision, and/or SwissPAR.

Fees

National Fees apply. Fees vary depending on the type of application. For full details see MHRA fees.

Overview of MHRA NASWSI approvals

The following is a list of procedures which reached a positive outcome after assessment through the Access Consortium NASWSI. For further information on these products, please refer to the MHRA Products page.

Product	Type of Procedure; MHRA Grant Date	New Indication
Vabysmo (faricimab)	Initial licence application; 16/05/22	Vabysmo is indicated for the treatment of adult patients with: neovascular (wet) age-related macular degeneration (nAMD) (see section 5.1). –Visual impairment due to diabetic macular oedema (DMO) (see section 5.1).
Scemblix (asciminib)	Initial licence application; 15/06/22	Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph + CML) in chronic phase (CP) , previously treated with two or more tyrosine kinase inhibitors, and without a known T315I mutation.
Orkambi granules (lumacaftor / ivacaftor)	Line extension and Type II Variations, to extend indication to children aged 1 to less than 2 years old; 17/03/23	Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (see sections 4.2, 4.4 and 5.1).
Vafseo (vadadustat)	Initial licence application; 19/05/23	Vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
Brukinsa (zanubrutinib)	Type II Variation to add follicular lymphoma indication; 30/01/24	– BRUKINSA as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. –BRUKINSA as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. –BRUKINSA as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL). –BRUKINSA in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
Vabysmo (faricimab)	Type II Variation to add macular oedema secondary to retinal vein occlusion indication; 31/07/24	Vabysmo is indicated for the treatment of adult patients with: Neovascular (wet) age-related macular degeneration (nAMD) (see section 5.1). Visual impairment due to diabetic macular oedema (DMO) (see section 5.1). Visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).
Fruzaqla (fruquintinib)	Initial licence application; 20/09/24	FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, with or without an anti-VEGF therapy, and if RAS wildtype and medically appropriate, an anti-EGFR therapy.
Opsumit (macitentan)	Line extension and Type II Variations, to extend indication to paediatric population	20/12/24
Opsumit (macitentan)	Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged 2 years to less than 18 years with WHO Functional Class (FC) II to III (see section 5.1).	20/12/24

How to apply

NASWSI: Interested applicants are invited to participate by contacting their regional regulatory authority using the NAS Expression of Interest (EOI) form (MS Word Document, 123 KB), 3-6 months prior to submission.

• United Kingdom: access-mhra@mhra.gov.uk
• Australia: PMABInternationalEvaluations@health.gov.au
• Canada: collaboration@hc-sc.gc.ca
• Singapore: HSA_TP_Enquiry@hsa.gov.sg
• Switzerland: Access@swissmedic.ch

Communications via email should include ‘Access Consortium – NASWSI’ in the subject line.

BSWSI: Interested applicants are invited to participate by contacting their regional regulatory authority using the Biosimilar Expression of Interest (EOI) form, 3-6 months prior to submission.

• United Kingdom: access-mhra@mhra.gov.uk
• Australia: PMABInternationalEvaluations@health.gov.au
• Canada: collaboration@hc-sc.gc.ca
• Singapore: HSA_TP_Enquiry@hsa.gov.sg
• Switzerland: Access@swissmedic.ch

Communications via email should include ‘Access Consortium – BSWSI’ in the subject line.

Guidance for UK requirements on submissions.