Guidance

All Integrated Scientific Advice (ISA) service application questions

Published 20 February 2026

How to use this guidance

This is a list of all the questions you will need to answer to apply for Integrated Scientific Advice (ISA) from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).

Use it to gather the information you’ll need before you apply online.

All applications must be completed and submitted using the request integrated scientific advice service.

Contact details

Primary contact details

Input the:

• full name

• job title

• job role

• email address

• phone number

Is there someone else we should contact about market access communications?

Choose yes or no.

Primary contact details for market access (if relevant)

Input the:

• full name

• job title

• job role

• email address

• phone number

Additional email addresses to include in communications about this advice (if needed)

Add up to 5 additional addresses.

Representative organisation name (optional)

Optional name

What is the name of the organisation you are requesting advice for?

Add the name.

What is the address of the organisation you are requesting advice for?

Add the full address.

What type of organisation are you requesting advice for?

Select one from:

• charity or not-for-profit organisation

• higher education institution

• healthcare provider (e.g. NHS Trust)

• micro business (less than 10 employees and turnover under £2 million)

• small business (less than 50 employees and turnover under £10 million)

• medium business (less than 250 employees and turnover under £50 million)

• large business (over 250 employees and turnover over £50 million)

• or add another type of organisation if not listed

Project details

What type of study are you requesting Integrated Scientific Advice for?

Select one from:

• First in Human study

• design of pivotal study

• pivotal study already started

• dose escalation study

• real-world evidence generation

• post authorisation trial

What area/s of expertise do you require from the MHRA?

Select all that apply:

• clinical

• non-clinical

• quality (aspects of manufacturing and control of product)

• pharmacovigilance or risk management plan

What area/s of expertise do you require from NICE?

Select all that apply:

• clinical

• cost-effectiveness

• real world evidence

Estimated Marketing Authorisation application date

Provide the estimated year and quarter.

Which regulatory route are you planning to take?

Select one from:

• national

• ACCESS

• Project Orbis

• International Recognition Procedure (IRP) 

Product information

Product name

Include:

• product name

• international Non-proprietary Name (optional)

• invented name (optional)

Therapeutic indication

Only include the indication. For example ‘treatment or prevention of…’ Do not provide any background information, the available space is up to 200 characters.

What is the prevalence of the condition in the United Kingdom?

Select from:

• equal to or less than 5 ion 10,000

• more than 5 in 10,000

What is the proposed legal status of the product?

Select one from:

• prescription

• non-prescription

• to be determined

What is your product type?

Select all that apply from 1,2 and 3:

1 - Biological

Active substance (either):

• established active substance

• new active substance

2 - Chemical

Active substance (either):

• established active substance

• new active substance

3 - Herbal

Does your product require an administration/medical device or an in vitro diagnostic (IVD)?

Choose yes or no.

If your our product does require an administration/medical device or an in vitro diagnostic (IVD) choose all that apply:

• associated medical device

• companion diagnostic

• other (you will need to provide details of your product if it is associated with something not listed above- be as specific as possible)

Patient information

Age

Select all that apply:

• paediatrics (newborn to 17)

• adult (18-65 years)   

• elderly (over 65 years)

Age range if you answered yes to paediatrics

Choose from:

• preterm newborn infants (up to gestational age <= 37 weeks)

• newborn (0-27 days)   

• infant and toddler (28 days-23 months) 

• children (2-11 years)   

• adolescents (12-17 years)

Sex

Select all from:

• male

• female

Other advice

Previous use of NICE advice services for this product

Choose yes or no.

If yes:

• what service/s you used, what dates and the project reference number/s

• when using the NICE service, were you discussing the same indication or use case - yes or no?

Have you received scientific advice from other authorities for this product?

Choose from:

• yes
• no
• applied but not received report (pending)

If you responded yes or you have applied for scientific advice from other authorities

Which authorities have you had advice from?

To help our experts fully understand the context of your advice request add:

• a brief description of the advice you received

• which regulatory agency the advice was from

• how many rounds of advice you received and the date received

If you received multiple reports on your product from an agency you should attach all relevant documents.


Have you received health technology assessment (HTA) advice from other authorities for this product?

Choose from:

• yes

• no

• applied but not received report (pending)

If you responded yes or you have applied for HTA advice from other authorities

Which authorities have you had advice from?

To help our experts fully understand the context of your advice request add:

• a brief description of the advice you received

• which regulatory agency the advice was from

• how many rounds of advice you received and the date received

If you received multiple reports on your product from an agency you should attach all relevant advice reports.


Questions you need advice on

Upload the the questions you need Integrated Scientific Advice on from the MHRA and NICE

Questions should be numbered and stated as clearly and simply as possible.

These questions are used to understand and cost your advice request. Any changes to these questions in the briefing book will result in an alteration to the cost of your advice.

Before uploading, name your document like this:

Question list-[Product name].pdf


For example: Question list-Calmexa.pdf

Scheduling

When do you need the final integrated scientific advice report? (optional)

Add the month and year.

Small and medium-sized enterprises (SME) status

Are you a small to medium company with SME status?

UK-based SMEs can apply for SME status from the MHRA which makes them eligible for a fee reduction from Integrated Scientific Advice fees.

Choose one from:

• yes - I want to apply and I have the Letter of Approval

• yes - I am an SME but I do not have a Letter of Approval

• no

If ‘Yes – I want to apply upload your SME status approval letter from the MHRA.

Finance details

Finance contact details

Input the:

• finance contact name

• email address

• phone number (optional)

Is the invoice address the same as the contact address?

Address will be shown from the organisation name and address previously added.

Choose from yes or no. If no, add the invoice address.

Do you need a purchase order (PO) number on the invoice?

Choose yes or no. Provide the PO number if available. You can leave this blank if it will be provided later.

Provide any additional financial documents (optional)

Upload up to 5 documents.

If your financial team requires the ISA finance team to complete and return any additional documents, write what you require in the box below and then upload the documents.



Examples of additional financial documents our finance team can assist with include a:

• security questionnaire for PO approval

• W-4 US tax withholding form

Information sharing

Can we contact you in the future to discuss the ISA service?

Choose yes or no. If yes, select all that apply from:

• contact the primary contact

• contact the additional contact