50 years

EU Pharmaceutical
regulation milestones

Legislative

Therapeutic

1964

The Declaration of Helsinki establishes
ethical principles for clinical research.

1965

EU decides that medicinal products need to be authorised before being placed on the market and develops structured medicinal regulations. Read more

1965

The Thalidomide disaster exemplifies the need for evidence-based authorisation.

1967

A new medicine added to the treatment of tuberculosis (rifampicin).

1968

A relief medicine for bronchospasm in asthma (salbutamol).

1971

A combination treatment for Parkinson’s disease (carbidopa/levodopa).

1972

A novel broad-spectrum antibiotic for bacterial infections (amoxicillin, clavulanate).

1974

An aromatase inhibitor to lower the risk of reoccurrence of breast cancer (tamoxifene).

1975

First steps towards a joint EU position on market authorisations through a multistate procedure and a common committee.

1976

Inhibitors of stomach acid production for treatment of peptic ulcers (cimetidine).

1980

A novel treatment for hypertension (captopril).

1982

The first synthetic insulin is produced.

1983

Member States agree on uniform way to summarise key characteristics of an authorised product.

1986

The first ever recombinant vaccine (for Hepatitis B).

1987

The concertation procedure is introduced: before authorising innovative products national authorities ask the opinion of an EU level Committee.

Rules for copies of branded medicines ("generics") are better defined.

1987

The first antiretroviral treatment for HIV/AIDS (zidovudine).

1989

Additional EU rules are adopted for the authorisation of vaccines and medicines derived from blood.

First Guidelines on Good Manufacturing Practices are published to improve the quality of medicines throughout the EU.

1989

The conjugated Haemophilus influenza vaccine to lower incidence of meningitis and pneumonia in children.

1990

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) provides a platform for international cooperation. Read more

1992

New rules harmonise the labelling of medicinal products, advertising, prescriptions and distribution.

Additional rules on homeopathic products are introduced.

1993

Agreement on a centralised, EU wide procedure for the authorisation of human and veterinary medicinal products. Read more

A new European Agency (EMA) will be responsible for scientific evaluations.

Mutual recognition of national authorisations is facilitated. Read more

1994

As part of the Council of Europe’s work, a European Network of medicines control laboratories is created.

1995

EMA - the European Medicines Agency starts business.
Read more

First centralised marketing authorisation is granted by the European Commission.

1995

A novel treatment for multiple sclerosis (interferon B).

1996

A rapidly acting insulin analogue.

1998

The first molecularly targeted cancer medicine (rituximab).

1999

A tumor necrosis factor inhibitor for treatment of rheumatoid arthritis (infliximab).

2000

To increase the number of products for rare diseases, new legislation is adopted (Orphan Regulation). Read more

For the first time, a patient representative is a full member of a scientific committee of the European Medicines Agency. Read more

2000

The first personalised medicine for treatment of breast cancer (trastuzumab).

2001

The Clinical Trial Directive provides requirements for the conduct of clinical trials in the EU. Read more

2001

The first two orphan medicinal products for treatment of a rare metabolic disorder, the Fabry disease (agalsidase alfa, agalsidase beta).

An innovative medicine for treatment of chronic myeloid leukaemia (imatinib).

2004

EU agrees on rules regarding Traditional Herbal Medicinal Products.

Cooperation of national authorities for the authorisation of products is further formalised.

Introduction of EU rules for copies of biological products ("biosimilars"). Read more

2006

EU adopts legislation on medicinal products for children.
Read more

2006

The Human Papilloma Virus vaccine to prevent cervical cancer.

2008

In the context of multiple myeloma thalidomide is authorized as a treatment.

2010

New EU pharmacovigilance rules strengthen the system for safety of medicines: better prevention, detection and assessment of adverse reactions to medicines, direct patient reporting of adverse events. Read more

2011

A novel treatment for melanoma (vemurafenib).

2012

The first gene therapy for the treatment of a severe fat metabolism disorder.

2014

New Clinical Trial Regulation simplifies procedures across EU and enables cross-border cooperation in international clinical trials.

2014

A new generation of antiviral medicines for treatment of chronic hepatitis C (sofosbuvir).

2015


EU decides that medicinal products need to be authorised before being placed on the market and develops structured medicinal regulations.

The use of the drug thalidomide in the 1960s caused thousands of infants to be born with birth defects.

Following this, the EC proposed the very first piece of pharmaceutical legislation, directive 65/65 – establishing the fundamental principle that medicinal products need to be independently evaluated and authorised before being placed on the market.

More structured drug regulations and control over drug use and development followed shortly after.

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) provides a platform for international cooperation.

The birth of ICH took place at a meeting in April 1990 in Brussels. The forum brings together the regulatory authorities and pharmaceutical industries of Europe, Japan and the United States.

The ICH works to ensure worldwide harmonisation for the quality, safety and efficacy of medicinal products.

Agreement on a centralised, EU wide procedure for the authorisation of human and veterinary medicinal products.

The centralised procedure, which was established in 1993 and came into operation in 1995, allows applicants to obtain a marketing authorisation for a medicinal product which will then be valid throughout the entire EU.

Mutual recognition of national authorisations is facilitated.

The mutual recognition procedure, which applies to the majority of conventional medicinal products, is based on the principle of recognition of an already existing national marketing authorisation by one or more Member States.

EMA - the European Medicines Agency starts business.

The European Medicines Agency (EMA), based in London, began operating in 1995.

The Agency is responsible for the scientific evaluation and supervision of medicines developed by pharmaceutical companies for use in the European Union.

To increase the number of products for rare diseases, new legislation is adopted (orphan regulation).

Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect no more than 5 in 10,000 people in the European Union.

Since only a very small number of the population is affected by these diseases, the pharmaceutical industry has been reluctant in the past to invest in the research and development of medicinal products to treat them.

In response, the EU introduced new legislation in 2000 which provides incentives for the development of orphan and other medicinal products for rare disorders.

To date, the European Commission has already authorised 108 orphan medicines for the benefit of patients suffering from rare diseases.

For the first time, a patient representative is a full member of a scientific committee of the European Medicines Agency.

The Committee for Orphan Medicinal Products was the first decision-making committee in the EU to include patient representatives as full members. This has not only stimulated dialogue with patient groups but has also had a positive impact on structuring patient groups’ work at EU level.

The levels of transparency at the EMA have been enhanced over the past five years, and the Agency has entered into a pro-active dialogue with all interested parties.

The Clinical Trial Directive provides requirements for the conduct of clinical trials in the EU.

Requirements for the conduct of clinical trials in the EU are provided for in the 2001 Directive on the approximation of the laws, regulations and administrative provisions of the Member States.

The Directive foresees good clinical practice in the conduct of clinical trials on medicinal products for human use.

Introduction of EU rules for copies of biological products (‘biosimilars’).

The European Commission issues the Decisions concerning the authorisation of these medicinal products on the basis of the scientific opinions from EMA. The resulting marketing authorisation is valid in all EU Member States.

The EU is the first region in the world to have set up a legal framework and a regulatory pathway for “similar biological medicinal products”, more commonly called “biosimilars”. The EU regulatory framework inspired many countries around the world e.g. Australia, Canada, Japan, Turkey, Singapore, South Africa, Taiwan, USA etc. as well as the World Health Organisation (WHO).

EU adopts legislation on medicinal products for children.

The Paediatric Regulation dramatically changed the regulatory environment for paediatric medicines in Europe. Its objective is to improve the health of children in Europe by facilitating the development and availability of medicines for children aged 0 to 17 years. This ensures that medicines for use in children are of high quality, ethically researched and authorised appropriately. This regulation also improves the availability of information on the use of medicines without subjecting children to unnecessary trials or delaying the authorisation of medicines for use in adults.

New EU pharmacovigilance rules strengthen the system for safety of medicines: better prevention, detection and assessment of adverse reactions to medicines, direct patient reporting of adverse events.

The EU legislation on pharmacovigilance foresees that once medicines are authorised and placed on the market, they continue to be monitored through the EU system of pharmacovigilance. This is to prevent, detect and assess possible adverse effects.

The reporting of adverse drug reactions is essential for effective pharmacovigilance and under the new legislation patients can report adverse drug reactions directly to the competent authorities.

Legislation against falsified medicines is adopted.

The Directive on falsified medicines obliges Member States to take the necessary measures in order to prevent unwanted medicinal products from entering into circulation in the EU if there are sufficient grounds to suspect that those products are falsified.

The Directive also foresees that the Commission may set up in a delegated act the criteria to be considered and the verifications to be made when assessing the potentially falsified character of those products.

It also introduces a "common logo" for websites of legally-operating online pharmacies/retailers. This logo has to be clearly displayed on every page of the website offering the medicinal products. The common logo shall be recognisable throughout the Union, while enabling the identification of the Member State where the online pharmacy/retailer is established.