Sector
Life Sciences & Pharma
Pharmaceuticals, biotechnology, medical devices and clinical research.
Start here
Run a clinical trial under the 2026 UK regime
The new UK clinical-trials framework is now fully in force — combined review, new transparency duties
Set up a scientific research operation
Setting up a research operation
Medical device compliance quick check
If you make or supply medical devices
Set up as a pharmaceutical manufacturer
Licensing and GMP for pharmaceutical manufacture
Responding to a medical device safety incident
Device safety incident? Start here
Who regulates you
See all 15HSE (opens in a new tab)
Workplace health, safety, and welfare regulation across all industries. Enforces the Health and Safety at Work Act 1974 and related regulations. Investigates serious incidents …
Enforces 13 Acts this sector relies on.
Environment Agency (opens in a new tab)
Environmental protection in England. Regulates waste, emissions, water quality, flood risk, and environmental permits for industrial activities. Enforces environmental law and issues permits for …
Enforces 6 Acts this sector relies on.
MHRA (opens in a new tab)
Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.
Enforces 6 Acts this sector relies on.
SEPA (opens in a new tab)
Scotland's principal environmental regulator. Protects and improves Scotland's environment. Issues environmental permits for waste, emissions, water abstraction, and radioactive substances. Enforces environmental law and …
Enforces 5 Acts this sector relies on.
DEFRA (opens in a new tab)
Government department responsible for environmental protection, food production and standards, agriculture, fisheries, and rural communities. Sets environmental policy and works with agencies (EA, NE) …
Enforces 4 Acts this sector relies on.
NRW (opens in a new tab)
Principal environmental regulator for Wales. Combines functions of Environment Agency Wales, Countryside Council for Wales, and Forestry Commission Wales. Issues environmental permits, manages natural …
Enforces 4 Acts this sector relies on.
Key legislation
See all 21General rules
Common requirements that apply across industries. Conditions such as employing people or operating premises are shown only after they are known.
File your confirmation statement
File a confirmation statement every 12 months, within 14 days after your review period ends. Filing late is a criminal offence for the company and its officers.
Applies across industries.
General ruleVerify your identity for Companies House as a director or PSC
Yes, if you are an individual director or PSC of a UK company, or an individual director of an overseas company registered in the UK. Corporate directors and officers of corporate PSCs are not yet required to verify. The transition for existing directors and PSCs ends on 17 November 2026.
Applies across industries.
General ruleMandatory registrations every business must complete
Step-by-step guide to the registrations every business must complete before trading, regardless of sector. Covers HMRC tax registration, ICO data protection fee, mandatory insurance, and pension auto-enrolment.
Applies across industries.
General rulePre-trading compliance checklist
A concise yes/no checklist to verify you have completed all mandatory pre-trading requirements, including business registration, tax, insurance, licences, premises approvals, and data protection.
Applies across industries.
General ruleMeet your business waste duty of care
Understand your legal responsibilities when producing, storing, or disposing of business waste. Covers using registered waste carriers, completing waste transfer notes, and the stricter rules for hazardous waste.
Applies across industries.
General ruleCheck if you need to register for VAT
Find out if your business must register for VAT based on your taxable turnover. Covers the £90,000 threshold, what counts as taxable turnover, the rolling 12-month test, and when voluntary registration makes sense.
Applies across industries.
All guidance for life sciences & pharma
Compliance & Legal
8
Scientific research and development: compliance checklist
Use this checklist to confirm your scientific research and development business meets its obligations. Work through the universal workplace items every R&D business shares, then the conditional items that depend on the type of research you do. If you answer no to any item, follow the linked guide before you proceed.
Relevant to a specific activity in this sector.
Manufacture controlled drugs and run a safe pharmaceutical site
A task guide for pharmaceutical manufacturers on the additional licence for controlled drugs and the duties that make a pharma site safe to run. It covers the Home Office controlled-drug licence, the environmental permit for large-scale chemical synthesis, and the workplace duties for hazardous substances, work equipment and general health and safety.
Relevant to a specific activity in this sector.
Pharmaceutical manufacturer: compliance checklist
A verification checklist for pharmaceutical manufacturers. Use it to confirm that active-substance registration, the manufacturer's / importer's authorisation with a Qualified Person and GMP, any Home Office controlled-drug licence, the environmental permit for large-scale synthesis and the workplace health-and-safety duties are all in place before a production run.
Relevant to a specific activity in this sector.
Meet your scientific research regulatory duties
Scientific research carries conditional regulatory duties on top of the universal workplace spine. This guide takes you through the five duties that apply depending on the type of work you do: COSHH for hazardous substances, GMO contained-use notification, animal research licensing, human tissue storage licensing, and ionising radiation controls. Each section tells you whether it applies to your operation.
Relevant to a specific activity in this sector.
Set up and run a safe scientific research operation
Whatever your research discipline — biotechnology, natural science, social science or humanities — you share the same workplace-safety foundation. This guide takes you through your general health and safety duty, fire safety, employers' liability insurance, equality and data protection. Put this spine in place first, then layer the conditional regulatory duties that apply to your specific research activities.
Relevant to a specific activity in this sector.
Which medicines manufacturing authorisation applies
A reference router for pharmaceutical manufacturers. Use it to work out which authorisation regime applies to what you make: active-substance registration for active pharmaceutical ingredients, a manufacturer's / importer's authorisation with a Qualified Person and GMP for finished medicines, and an additional Home Office licence if you make or handle controlled drugs.
Relevant to a specific activity in this sector.
Get authorised to manufacture medicines: MHRA licensing, active-substance registration and GMP
A task guide for pharmaceutical manufacturers on getting the right MHRA authorisation in place before they operate. It covers active-substance registration for makers of active pharmaceutical ingredients, and the manufacturer's / importer's authorisation with a Qualified Person and Good Manufacturing Practice for makers of finished medicines, in the order you need them.
Relevant to a specific activity in this sector.
Which scientific research and development regulations apply to your business
Scientific research businesses share universal workplace duties and then carry conditional duties that depend on the type of work you do — from genetically modified organisms and animal research to human tissue and ionising radiation. Most social-science and humanities R&D triggers only the universals.
Relevant to a specific activity in this sector.
Show 5 more
Biocides and Pesticides Authorisation
Get HSE CRD authorisation for biocidal and pesticidal products.
Relevant to a specific activity in this sector.
UK REACH Chemical Compliance
Understand and comply with UK REACH chemical registration requirements for manufacturers and importers.
Relevant to a specific activity in this sector.
CLP Chemical Classification and Labelling
Classify, label and package hazardous chemicals under GB CLP.
Relevant to a specific activity in this sector.
COMAH Compliance for Chemical Sites
Meet COMAH requirements for sites holding dangerous substances.
Relevant to a specific activity in this sector.
Get authorisation for a water activity in Scotland (EASR)
How to get authorisation for any activity affecting surface water or groundwater in Scotland — abstraction, impoundment, engineering in or near a water body, and discharges. Since 1 November 2025 water activities are authorised under the Environmental Authorisations (Scotland) Regulations 2018 (EASR), which replaced the Controlled Activities Regulations (CAR 2011) framework. Covers the four-tier authorisation system (General Binding Rules, notification, registration, permit), pre-application advice, fees, and enforcement, all administered by SEPA.
Relevant to a specific activity in this sector.
Sector-Specific
3
Medicines and controlled drugs compliance
Legal requirements for handling, storing and administering medicines including controlled drugs in healthcare settings.
Relevant to a specific activity in this sector.
MHRA authorisation for medicines and medical devices
How to obtain MHRA authorisation for medicines and medical devices in the UK. Covers Marketing Authorisations, wholesale dealer licences, manufacturer licences, and medical device registration including UKCA vs CE marking.
Relevant to a specific activity in this sector.
MHRA licensing for medicines and medical devices
MHRA licensing requirements for manufacturing, distributing, and importing medicines and medical devices in the UK.
Relevant to a specific activity in this sector.
Subsectors
SIC 2007 divisions covered by this sector.