HSE (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.
Sector
Life Sciences & Pharma
Pharmaceuticals, biotechnology, medical devices and clinical research.
- Guides
- 14
- Regulators
- 12
- Legislation
- 16
- Journeys
- 3
Start here
Step-by-step routes through what life sciences & pharma businesses must do.
Ranked by how thoroughly each journey maps this sector's guidance.
Journey
Water Framework Directive compliance for businesses
Complete compliance pathway for businesses whose activities may affect water body status — from understanding the WFD framework through identifying which licences, permits, or consents you need, to applying, monitoring, and reporting. Covers England, Wales, Scotland, and Northern Ireland.
JourneySet up a scientific research operation
Learning path for new scientific research and development businesses — biotechnology labs, natural-science R&D, social-science R&D and humanities research. Work out which rules apply, put a safe workplace in place, meet the conditional regulatory duties for your type of research, and verify everything with a compliance checklist.
JourneySet up as a pharmaceutical manufacturer
Learning path for new pharmaceutical manufacturers. Work out which MHRA authorisation applies to what you make, get registered or licensed with a Qualified Person and Good Manufacturing Practice, add a Home Office licence and the right permits and safety controls for your site, and verify everything with a compliance checklist.
Who regulates you
See all 12The bodies that set rules and enforce compliance for life sciences & pharma.
Ranked by how much of the legislation this sector's guides cite each one enforces.
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.
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.
MHRA (opens in a new tab)
Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.
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 16The Acts and statutory instruments that set duties for this sector.
Ranked by how many of this sector's guides cite each — the legislation most central to the sector appears first.
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SI
Human Medicines Regulations 2012 (opens in a new tab) Cited by 3 of this sector's guides
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Act
Misuse of Drugs Act 1971 (opens in a new tab) Cited by 3 of this sector's guides
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Act
ASPA 1986 (opens in a new tab) Cited by 2 of this sector's guides · 104 provisions
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Act
Medicines and Medical Devices Act 2021 (opens in a new tab) Cited by 2 of this sector's guides
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SI
Ionising Radiations Regulations 2017 (opens in a new tab) Cited by 2 of this sector's guides
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Act
Human Tissue Act 2004 (opens in a new tab) Cited by 2 of this sector's guides
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SI
The Genetically Modified Organisms (Contained Use) Regulati… (opens in a new tab) Cited by 2 of this sector's guides
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SI
REACH (Amendment ) (EU Exit) Regulations 2019 (opens in a new tab) Cited by 1 of this sector's guide
All guidance for life sciences & pharma
14 guides for this sector.
Grouped by topic area, with the topic holding the most guidance first; within each, the most comprehensive guides lead.
Sector-Specific
9 guides
- Pharmaceutical manufacturer: compliance checklist A verification checklist for pharmaceutical manufacturers (SIC division 21). Use it to confirm that active-substance registration, the manufacturer's / importer's …
- Manufacture controlled drugs and run a safe pharmaceutical site A task guide for pharmaceutical manufacturers (SIC division 21) on the additional licence for controlled drugs and the duties that …
- Control and monitor air emissions How to comply with air emissions permit conditions for Part A and Part B regulated activities. Covers the difference between …
- Which medicines manufacturing authorisation applies A reference router for pharmaceutical manufacturers (SIC division 21). Use it to work out which authorisation regime applies to what …
- UK REACH Chemical Compliance Understand and comply with UK REACH chemical registration requirements for manufacturers and importers.
- Get authorised to manufacture medicines: MHRA licensing, active-substance registration and GMP A task guide for pharmaceutical manufacturers (SIC division 21) on getting the right MHRA authorisation in place before they operate. …
- Biocides and Pesticides Authorisation Get HSE CRD authorisation for biocidal and pesticidal products.
- COMAH Compliance for Chemical Sites Meet COMAH requirements for sites holding dangerous substances.
- CLP Chemical Classification and Labelling Classify, label and package hazardous chemicals under GB CLP.
Compliance & Legal
5 guides
- 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 …
- Scientific research and development: compliance checklist Use this checklist to confirm your scientific research and development business (SIC division 72) meets its obligations. Work through the …
- 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 …
- 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 …
- 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 …
Subsectors
SIC 2007 divisions covered by this sector.