General Information - EU Regulatory Affairs a Historic Perspective

Question 1

What was the first European healthcare regulation concerning ethical treatment of humans subjects?

Answer 1

Helsinki Declaration in 1964

Question 2

What were the two major events with unsafe products in Europe?

Answer 2

1) Thalidomide scandal (Contergan) in late 1950’s

2) BSE and TSE (Creutzfeldt-Jakob) in British beef

Question 3

What are the two major objectives of European Pharmaceutical Legislation since 1965?

Answer 3

1) Protection of public health

2) Free movement of products among Member States

Question 4

What series of volumes comprises the legal framework for medicinal products for both human and veterinary use?

Answer 4

The Rules Governing Medicinal Products in the European Union

Question 5

What comprises the legal framework for medicinal products for both human and veterinary use?

Answer 5

1) Pharmaceutical legislation (directives, regulations, decisions and other communications of the European Council and the European Commission)
2) Notice to Applicants describing administrative procedures for MAs and the MAA dossier format
3) Guidelines
4) Good Manufacturing Practice guide
5) detailed drug monitoring (pharmacovigilence) guide

Question 6

What are the subcategories for guidelines?

Answer 6

1) Quality and technology
2) Safety, environment and information
3) Efficacy (clinical guidance)

Question 7

What was the first European medical product directive?

Answer 7

Council Directive 65/65/EEC (later codified into the unified Directive 2001/83/EC)

Question 8

What did Council Directive 75/318/EEC (later codified into the unified Directive 2001/83/EC in article 8(3)(a)-(i)) define?

Answer 8

Legal requirements relating to MAA analytical, pharmacotoxicological and clinical documentation

Question 9

What did the 1991 Directive 91/356/EEC describe?

Answer 9

GMP principles (which Member States incorporated over the next 10 years)

Question 10

What did the 1992 Directive 92/26/EEC (later codified into the unified Directive 2001/83/EC in Articles 70-75) describe?

Answer 10

Prescription status

Question 11

What did the 1992 Directive 92/27/EEC (later codified into the unified Directive 2001/83/EC in Articles 54-69) describe?

Answer 11

Medicinal product labelling and package leaflets

Question 12

What did the 1992 Directive 92/28/EEC (later codified into the unified Directive 2001/83/EC in Articles 86-100) describe?

Answer 12

Medicinal product advertising

Question 13

At the end of 2001, the European Council adopted what directive?

Answer 13

Medicinal Products Directive (Directive 2001/83/EC) replacing all previous medicinal product directives

Question 14

Directive 2002/98/EC

Answer 14

Setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components

Question 15

Directive 2003/63/EC

Answer 15

Establishing the analytical, pharmacotoxicological and clinical standards and protocols for medicinal product testing

Question 16

Directive 2004/24/EC

Answer 16

Traditional herbal medicinal products

Question 17

Directive 2004/27/EC

Answer 17

GMP process requirements for APIs

Question 18

Regulation (EC) No 1901/2006

Answer 18

Medicinal products for paediatric use and amendments

Question 19

Council regulation (EC) No 1394/2007

Answer 19

Advanced therapy medicinal products

Question 20

Directive 2008/29/EC

Answer 20

Medicinal products for human use, as regards the implementing powers conferred on the Commission

Question 21

Directive 2009/53/EC

Answer 21

Variations to the terms of MAs for medicinal products

Question 22

Directive 2010/84/EU

Answer 22

Amending , as regards to pharmacovigilence, Directive 2001/83/EC on the Community code relating to medicinal products for human use

Question 23

Directive 2011/62/EU

Answer 23

Prevention of the entry into the legal supply chain of falsified medicinal products

Question 24

Where is EMA headquartered?

Answer 24

London (provides the administrative center and support for MAA reviewers)

Question 25

What are the six scientific committees that conduct technical review of all Centralised Procedure applications?

Answer 25

1) Committee for Medicinal Products for Human Use (CHMP)
2) Committee for Medicinal Products for Veterinary Use (CVMP)
3) Committee on Orphan Medicinal Products (COMP)
4) Committee on Herbal Medicinal Products (CHMP)
5) Committee for Advanced Therapies (CAT)
6) Paediatric Committee (PDCO)

Question 26

COMP’s role in reviewing orphan products is defined in which regulation?

Answer 26

Regulation (EC) 141/2000

Question 27

The roles of CHMP and CVMP in reviewing medicinal products for humans and animals are described in which regulation?

Answer 27

Regulation (EC) 726/2004

Question 28

Medicinal products that do not meet Centralised Procedure criteria may receive MAs through which two mechanisms?

Answer 28

1) National registration

2) Decentralised mutual recognition (commonly referred to as mutual recognition)

Question 29

Which products qualify for National registration?

Answer 29

Products that do not qualify for centralised approval and are intended for marketing in only one EU country.

Question 30

Mutual recognition procedure

Answer 30

If the intent is to market the product in more than one country

Question 31

Decentralised Procedure

Answer 31

Should be used for products for which no MA exists. IN essence the MAA will be evaluated by one Member State (chosen by the company) that will act as the Reference Member State (RMS). If an MA is granted by that state, other Member States (chosen by the company, known as the Concerned Member States (CMS) are asked to “mutually recognise” the RMS aproval. IF the approval is recognised, a MA will be granted in all the CMS.