Regulatory Requirements of European Union (EU)

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Regulatory Requirements of European Union (EU)

• By
• Dr. Neelam
• M.M. College of Pharmacy,
• Maharishi Markandeshwar (Deemed to be University)
• Mullana, Ambala, Haryana

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Introduction

• The European Union(EU) is a politico-economic
  union of 28 members states that are primarily
  located in Europe.
• The main institutions of the EU are The European
  Commission, The council of the EU, The court of
  Justice of EU, The European Court of Auditors,
  and the European Parliament.
• The European Parliament is elected by the EU
  citizens every 5 years.
• In 2004, the EU became the first region in the
  world to set up a legal framework and a
  regulatory pathway for Biosimilars or Similar
  biological medicinal products.

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Introduction

• European Council The European council brings
  together EU leaders to set the EUs political
  agenda.
• European Commission The European Commission is
  the EUs politically independent executive arm.
  It is alone responsible for drawing up proposals
  for new legislation, and it implements the
  decision of European Parliament and the Council
  of the EU.
• Court of Justice of the European Union The court
  of Justice interprets EU law to make sure it is
  applied in the same way in all EU countries, and
  settles legal disputes between national
  government and EU institutions.

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European Drug Regulatory Authorities

• 1. EUROPEAN MEDICINES AGENCY(EMA)

• EMA was established in 1995 and from 1995 to 2004
  it was known as European agency for the
  evaluation of medicinal products.
• The European Medicines Agency(EMA) is responsible
  for the scientific evaluations, supervision and
  safety observation of medicines in the EU.
• The regular functions of EMA are carried out by
  EMA staff and supervised by EMAs executive
  director.
• EMA is a networking organisation whose
  functioning involves thousands of experts all
  over the Europe.

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• Organizational Structure of EMA

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• Responsibilities of EMA

• To provide independent, science based
  recommendations based on the quality, safety and
  efficacy of medicines.
• To apply efficient and transparent evaluations
  procedures for helping in bring new medicines.
• To recommend safety limits for residue of
  residues of veterinary medicines administered to
  food-producing animals.
• To develop best practice for medicines
  evaluations and supervision in Europe.
• To publish unbiased and logical information
  regarding medicines and its use.

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• 2. CLINICAL TRIALS IN EU

• Clinical trials are research studies that test
  how well new medical approaches work in people.
• Each study answers scientific questions and tries
  to find better ways to prevent, screen for,
  diagnose or treat a disease.
• Clinical trials may also compare a new treatment
  to a treatment that is already available.
• The authorisation and oversight of a clinical
  trial is the responsibility of the member state
  in which the trial is taking place.
• The European Clinical Trials Database tracks
  which clinical trials have been authorised in EU.

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• 2.1 CHAPTER 1 Application and Application Form

• Detailed guidance for the request for
  authorization of a clinical trial on a medicinal
  product for human use to competent authorities.
• Detailed guidance on the application format and
  documentation to be submitted in an application
  for an Ethics Committee opinion on the clinical
  trials on medicinal products for human use.
• Detailed guidance on the European clinical trials
  database (EudraCT).
• 2.2 CHAPTER 2 Safety Reporting
• Detailed guidance on the collection, verification
  and presentation of adverse reaction reports from
  clinical trials.
• ICH guidance E2F-Note for guidance on development
  safety update reports.

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• 2.3 CHAPTER 3 Quality of the Investigational
  Medicinal Product
• Good manufacturing practices for manufacture of
  investigational medicinal products.
• Guidelines on the requirements to the chemical
  and pharmaceutical quality documentation
  concerning investigational medicinal products in
  clinical trials.
• 2.4 CHAPTER 4 Inspections
• Guidance for the preparation of GCP inspections.
• Guidance for the conduct of GCP inspections.
• 2. CHAPTER 5 Additional Information
• Guidelines on good clinical practice .
• Recommendation on the content of the trial master
  file and archiving.

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• 2.6 CHAPTER 6 Legislation

• Directive 2001/20/EC of the European Parliament
  and of the Council of 4 April 2001 on the
  approximation of the laws, relating to the
  implementation of good clinical practices in the
  conduct of clinical trials on medicinal product
  for human use.
• Commission Directive 2005/28/EC of 8 April 2005
  laying down principles and detailed guidelines
  for good clinical practice as regards
  investigational medicinal products for human use.

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• 3. MARKETING AUTHORISATION IN EU

• A medicinal product can only be marketed in the
  European Economics Area when a marketing
  authorisation has been granted by the Competent
  Authority of a member state for its own specific
  territory.
• There are several alternatives procedure which
  can be used to obtain the authorisation depending
  on the type of the medicinal product and the
  countries where the product is intended to be
  marketed.

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• 3.1 Centralised Procedure in EU

• A marketing authorization granted under the
  centralized procedure is valid for all the
  countries in the entire EU market.
• The application is submitted to the EMA for the
  medicinal products which fall within the
  mandatory scope of the centralized procedure.
• The centralized procedure is compulsory for
  certain types of human medicinal products such as
  designated orphans, advanced therapy medicinal
  products, those contains new active substance for
  the treatment of cancer, diabetes, and other
  immune dysfunctions.

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• 3.2 Decentralised Procedure in EU

• The decentralised procedure can be used in cases
  where the product has never been authorised in
  any Member states, and the applicant wishes to
  obtain a license in a number of states
  simultaneously.
• The applicant must submit application with the
  complete dossier to the Competent Authorities of
  each Member States where authorisation is
  desired.
• The review process has many parallels with the
  centralised procedure , in that similar timelines
  exist, the Reference Member States(RMS) plays the
  role of rapporteur, and the Concerned Member
  States(CMS) replace the CHMP.

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• 4. PRICING AND REIMBURSEMENT

• Once a marketing authorization has been granted,
  decision about price and reimbursement take place
  at the level of each Member States considering
  the potential role and use of the medicine in the
  context of the national health system of that
  country.
• Pricing and reimbursement agencies, HTA bodies or
  payers rely upon these assessments to
• Determine reimbursement status
• Provide information on benefits and risks of new
  treatments.
• Support the process of price negotiation.

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• 5. INTERNATIONAL COOPERATION

• The European commission and EMA, in close
  cooperation with Member States, work to forge
  close ties with partner organization around the
  world.
• These activities aims to foster the timely
  exchange of regulatory and scientific expertise
  and development of best practice in the
  regulatory field across the world.
• The European Commission and EMA work with the
  World Health Organization (WHO) to improve the
  quality of the medicines and the development of
  international non-proprietary names.

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