History of Regulations (Ch. 2) Flashcards
When was the EU formed?
1957: EEU - European Economic Union was formed to create a single European market to allow people, products, and services to move freely
Renamed to the EU in 1992
What is the benefit of harmonized legislation?
No conflicting requirements, and all countries are in agreement
What is the structure of EU legislation (primary, secondary, etc.)?
Primary Legislation: EU Treaty
Secondary Legislation: Directives and regulations, decisions, opinions, and recommendations
Other: Guidances (MEDDEVs), harmonized standards,
What is a directive?
Directive: obliges Member States to implement its provisions into National Laws
What is a regulation?
Regulation: directly applicable in all Member States, and obliges Member States to remove any conflicting provisions from national legislation
What is the EU MDR regulation?
EU Medical Devices Regulation (EU MDR):
Regulation (EU) 2017/745
What is the EU IVDR regulation?
EU In Vitro Diagnostics Regulation (EU IVDR):
Regulation (EU) 2017/746
What are EPARs?
EPAR: European Public Assessment Reports
- contain detailed info on the approval/rejection of a product
What are NPARs?
NPAR: National Public Assessment Reports
- contain approval/rejection info on a national level
TRUE/FALSE: Patient involvement and representation in the regulatory process is increasing.
True
What is the purpose of the Transparency Directive (Council Directive 1989/105/EEC)?
Transparency Directive (Council Directive 1989/105/EEC): Includes minimum procedural safeguards ensuring national cost-containment measures regulating the pricing of medicines were transparent
What is the BeNeLuxA Initiative?
BeNeLuxA Initiative:
Collaboration on pharmaceutical pricing
What is the purpose of the Falsified Medicines Directive (FMD, Directive 2011/62/EU)?
Falsified Medicines Directive (FMD, Directive 2011/62/EU):
- To prevent the distribution of falsified medical products, includes authenticity features
What are the two types of harmonized product legislation?
- The Traditional Approach
2. The New Approach
What is the Traditional Approach?
Traditional Approach:
Implies the inclusion of detailed technical specifications in the law - highly detailed, extensive laws
What is the New Approach?
New Approach:
Includes Essential Requirements for safety and performance in the core legal text, and publishing the technical specification in harmonized standards - reduces regulatory burden, increases development
(introduced in the 1980’s)
Pharmaceutical and medical device regulations are based on what principle?
A positive balance between benefit and risk principle
What is the first European Medicinal Products Directive?
Council Directive 65/65/EEC
- detailed requirements for medicinal products for human use and MA requirements
What is the Centralized Procedure?
Centralized Procedure:
Enables a single medicinal product MA for the entire EU
What is the National Procedure?
National Procedure:
For medicinal products that are not qualified for centralized approval, and are intended for marketing in only one EU Member State
What is the process for the Mutual Recognition Procedure and the Decentralized Procedure?
The MAA is evaluated by one Member State (Reference Member State: RMA), and the evaluation is recognized by other Member States
When do the Mutual Recognition Procedure and the Decentralized Procedure apply?
Mutual Recognition Procedure: Applies if the applicant already has an MA in one EU Member State
Decentralized Procedure: Applies if the applicant seeks simultaneous authorization in more than one Member State
Directive 2001/83/EEC was an act of codification, what were the benefits of this?
Codification combined the contents of all previous directives and simplified, unified, and clarified all regulatory requirements
What is the purpose of the Variations Directive, Commission Regulation (EC) No. 1234/2008?
Variations Directive, Commission Regulation (EU) No. 1234/2008:
To address variations/extensions to marketing authorizations
What are biologics?
Vaccines, blood derivatives, allergens, somatic cells, gene therapies, and tissue proteins
What is the VAMF?
VAMF: Vaccine Antigen Master File
- allows a single evaluation of a vaccine antigen
What is the BWP?
BWP: Biologics Working Party
- Provides recommendations on all matters related to biological and biotechnical medicines
What is the purpose of the Regulation (EC) No. 1394/2007 (ATMPs)?
Regulation (EC) No. 1394/2007:
Included ATMPs in the pharmaceutical regulation
(ATMP: Advanced Therapy Medicinal Products)
What is the purpose of the Directive 2004/27/EC (biosimilars)?
Directive 2004/27/EC:
Added requirements for an MAA based on the demonstration of similarity of two biological medicinal products
What two areas do veterinary regulations cover?
- Veterinary medicines’ quality, safety, and efficacy (mirror human medicines)
- Safety of residues in treated animals’ foodstuffs
What is the purpose of Directive 2004/24/EC (herbal products)?
Directive 2004/24/EC:
Established a simplified application for traditional herbal medicinal products
What is the CE mark?
Conformite Europeenne (CE), or European Conformity Mark Indicates the product complies with all applicable EU legislation and can be considered the "passport" to the EU single market
What is the difference between Essential Requirements and technical requirements?
Essential Requirements for safety and performance: included in the legal texts
Technical specifications and requirements: Described in standards
What is standardization?
Standardization:
The process of drafting standards and then the standard being approved by a recognized standardization body
What is a harmonized standard?
- A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI
- Can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.
Where does the Commission publish harmonized standards?
The Official Journal
What is the Blue Guide?
Blue Guide:
A guide to the implementation of directives based on the New Approach and the Global Approach
(has a blue cover)
What is presumption of conformity (as relates to harmonized standards)?
Presumption of conformity:
means that if the product complies to the harmonized standard, the product is presumed by the Member States to be in conformity with the Essential Requirements
What is the core legal framework for medical devices?
Council Directive 90/385/EEC: AIMDD (Active Implantable Medical Devices)
Council Directive 93/42/EEC: MDD (Medical Devices Directive)
Directive 98/79/EC: IVDD (In Vitro Diagnostics Medical Devices Directive)
What are the key elements of the MDD?
- Conformity assessment procedure routes
- Classification Rules based on risk
- Notified body approval / CE-mark
What are the 4 classes of medical devices?
Class I: low-risk
Class IIa and IIb: medium-risk
Class III: high-risk
What are Notified Bodies?
Notified Bodies:
Private organizations with special legal status that are designated by national competent authorities to check manufactures’ conformity assessment procedures and grant certificates according to the requirements
What is Directive 2007/47/EC?
Directive 2007/47/EC:
Amended 93/42/EEC and 90/385/EEC, included software, added checks of representative samples of design dossiers by notified bodies, and extended clinical evaluation obligations
What are IVDs?
IVD: In Vitro Diagnostic Medical Device
Reagents, reagent products, calibrators, control materials, kits, instruments, apparatus, equipment or systems to be used for the in vitro examination of human samples to make a medical diagnosis
True/False: The MDD and IVDD classification systems are rule based.
False - The IVDD classification system is not rule-based, but instead includes a list of regulated products. (To be updated in the IVDR)
