GW’s vision is to be the leader in prescription cannabinoid medicines, developing and commercialising pharmaceutical products, which address clear unmet needs.
Our mission inspires the work we do to transform the lives of our patients, and our values guide the way in which we do it.
- Patient driven – We never forget who we're striving for
- Passionate – We are here to change lives
- Innovative – We challenge ourselves to find new and better approaches
- Collaborative – We accomplish more through working together and valuing one another
- Accountable – We take responsibility and deliver on our commitments
- Integrity – We are fair, honest, and ethical
- Excellence – We pursue the highest standards for ourselves and for our industry
GW believes passionately in the potential therapeutic benefits of the cannabis plant and firmly believes that cannabis-based medicines have potential to improve the lives of patients and families.
Over the past two decades we have established extensive experience in researching, developing and delivering novel, breakthrough medicines, undertaking pioneering work to unlock the medical benefit of cannabis through rigorous scientific investigation, extensive clinical trials and regulatory approvals.
Looking to the future, GW is committed to leveraging our experience, expertise and extensive body of research in cannabinoid science to treat other diseases where significant unmet need exists.
- 1998 GW Pharmaceuticals is founded
- 1999 First clinical trials involving cannabinoids commence
- 2007 Preclinical research into epilepsy begins
- 2010 Sativex gains UK and Canadian approval
- 2013 Clinical trials begin on our highly purified CBD product
- 2015 Greenwich Biosciences is founded as GW Pharmaceuticals' US subsidiary
- 2018 Epidiolex gains US approval
- 2019 Epidyolex gains EU approval
- 2020 Sativex approved in 25+ countries around the world
- 2020 Epidyolex gains Australian approval
Where are we today
GW’s pioneering work has led to the regulatory approval of world first, potentially life improving, cannabis-based medicines.1,2,3 Our continued dedication to research and development in this field has resulted in the treatment of thousands of patients with our medicines.
Much of what is known about the medical uses of cannabis was discovered by GW – we have led the way in understanding cannabinoid science and how, if harnessed correctly, it has the potential to improve the lives of patients and their families.
By applying scientific and medical rigour to our understanding of the cannabis plant, we have already been able to bring two potentially life improving cannabis-based medicines to patients.
countries GW’s medicines approved in4
patient-years of human safety data from postmarketing sources5
invested in infrastructure and facilities6
invested in R&D activities, facilities and infrastructure7
patients globally involved in clinical trials8
Working in partnership with respected physicians, scientists and subject matter-experts around the world, our team has created the equipment, methods, scientific platform and defined standards that ensure we are a world leader in the cannabinoid field. Through this process we have honed our ability to manufacture and supply our high-quality medicines to the large number of patients that need them.
We have also partnered with regulators, legislators, payors and the medical community to find a way forward for these novel medicines. By catalysing change within the current system, we have made our cannabis-based medicines more accessible and established a roadmap for a new area of medicine that others could follow.
For more information on the EU regulatory approval system for medicines, please see below:
Study evidence requirements
Medicines must be studied in regulatory compliant, controlled, clinical trials in large groups of subjects to determine safety, efficacy and quality. Public disclosure of clinical trials required.
Manufacturing facilities must be inspected and compliant, according to regulated and current Good Manufacturing Practices (cGMP).9
Under GMP, approved medications must adhere to strict specifications that ensure batch-to-batch consistency and a stable shelf life.10
Every medicine must meet national or European regulatory agency standards for quality (including purity, stability and batch-to-batch consistency). Each batch of product is tested against the manufacturing product specification as agreed by the regulators at product approval. Ensuring that approved medicines contain consistent concentrations of active ingredients and other product ingredients listed on the label, including impurities and degradants.9-11
This allows for specific product removal from the market, verification of authenticity or individual batch recall if safety concerns are identified.
Once approved, medicines can be legally prescribed in every country the product is approved in.9
Pharmacovigilance and safety monitoring
Activities which aim to detect, assess, understand and prevent the side effects of medicines are carried out to enhance patient care and patient safety. Reliable and balanced information supports public health by allowing the effective assessment of a medicine’s risk-benefit profile.12
Reimbursement of prescription medicines is organised and approved at a national level, but will often require or be helped by approval and/or recommendation from an international regulatory organisation.9
Fda.gov. (2018). FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. [online] Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms [Accessed Nov 2020].
Ema.europa.eu. (2018). European Medicines Agency – Epidyolex European public assessment report. [online] Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/epidyolex [Accessed Nov 2020].
Health Canada (2005). Factsheet: Approval of SATIVEX® with Conditions. [online] Available at: https://www.canada.ca/en/healthcanada/services/drugs-health-products/drug-products/notice-compliance/conditions/fact-sheet-sativex.html [Accessed Nov 2020].
Data on file (Countries in which GW’s medicines have been approved – >40) – VV-MED-12406.
Data on file (The level of human safety estimated patient-years – >135,000) – VV-MED-12269.
Data on file (Total infrastructure investment globally - £652m) – VV-MED-12076.
Data on file (Total investment globally – >£1.3bn) – VV-MED-12367.
Data on file (Total number of patients globally involved in GW clinical trials – >8,000) – VV-MED-12266.
European regulatory system for medicines: A consistent approach to medicines regulation across the European Union: EMA/716925/2016. European Medicines Agency, 2016.
ICH Harmonised Guideline: GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS (ICHQ7A) [Current Step 4 version dated 10 November 2000].
DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Who.int. (2020). World Health Organization – Pharmacovigilance. [online] Available at: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/ [Accessed Nov 2020].