Overview of Regulatory Environment USA, Europe and India

Overview of Regulatory Environment (India)

1. Regulatory Environment in India

• India has a well-defined, multi-ministerial drug regulatory system.
• Regulation of drugs, medical devices, biologics, and r-DNA products is shared among different ministries.
• Central and State authorities work together for approval, licensing, quality control, and monitoring.

2. Central Regulatory Authority

CDSCO (Central Drugs Standard Control Organization)

• Principal regulatory body for:
• Drug approval
• New drug development
• Clinical trials
• Import & marketing authorization
• Functions under:
• Ministry of Health & Family Welfare (MoHFW)

3. State Regulatory Authorities

• State Drug Control Organizations
• Issue licenses for manufacture, sale, and distribution of approved drugs
• Monitor drug quality at state level
• Work in coordination with CDSCO

India – Well Defined Drug Regulatory System

A. Ministry of Health & Family Welfare

Hierarchy:

• DGHS (Directorate General of Health Services)
• CDSCO
• DCGI (Drugs Controller General of India)
• DTAB (Drugs Technical Advisory Board)

Key Functions:

• Approval of new drugs
• Clinical trial oversight
• Medical devices regulation
• Pharmacovigilance

Divisions under CDSCO:

• Enforcement & GMP Audit Division
• Quality Control Division (CDTL)
• Registration Division
• New Drugs Division
• Pharmacovigilance
• Training & Capacity Building

B. Ministry of Chemicals & Fertilizers

Department of Pharmaceuticals

• Responsible for pharmaceutical industry policy
• Oversees:
• NPPA (National Pharmaceutical Pricing Authority)

NPPA Functions:

• Drug price control
• Monitoring prices of essential medicines
• Ensuring availability of affordable drugs

C. Ministry of Commerce

Patent Office

• Handles:
• Drug patents
• Intellectual Property Rights (IPR)

Controller General of Patents

• Grants patents for pharmaceuticals and biotechnology products

D. Ministry of Science & Technology

Research & Innovation Bodies:

• ICMR – Indian Council of Medical Research
• DBT – Department of Biotechnology
• CSIR Laboratories

Role:

• Biomedical research
• Biotechnology product development
• Support for translational research

Key Teaching Takeaways (Exam Points)

• CDSCO is the central drug regulatory authority in India.
• DCGI is the head of CDSCO.
• Licensing is mainly done by State Drug Authorities.
• Drug pricing is controlled by NPPA, not CDSCO.
• Patents fall under Ministry of Commerce, not Health.
• Research bodies like ICMR & CSIR do not approve drugs but support R&D.

REGULATORY BODIES IN INDIA (Pharmaceutical & Biomedical)

a) Drugs Controller General of India (DCGI)

• Head of CDSCO
• Main authority for:
• Approval of clinical trials
• Approval of new drugs
• Regulation of imported drugs
• Oversight of biologics and medical devices
• Ensures safety, efficacy, and quality standards
• Functions under Ministry of Health & Family Welfare

📌 Exam note: DCGI is not a separate organization, but the statutory head of CDSCO.

b) Indian Council of Medical Research (ICMR)

• Apex body for biomedical research in India
• Conducts and promotes:
• Clinical research
• Epidemiological studies
• Public health research
• Provides ethical guidelines for biomedical and health research

📌 Exam note: ICMR does not approve drugs; it supports research and ethics.

c) Drugs Consultative Committee (DCC)

• Statutory advisory body under Drugs & Cosmetics Act
• Provides technical advice to:
• CDSCO
• Central and State Governments
• Ensures uniform implementation of the Drugs & Cosmetics Act across states

d) Central Drugs Laboratory (CDL)

• National reference laboratory
• Responsible for:
• Quality control testing of drugs
• Analysis of samples referred by courts or regulators
• Supports enforcement of drug quality standards

📌 Exam note: CDL is different from CDTL, which works directly under CDSCO.

e) Central License Approving Authority (CLAA)

• Grants central approval for:
• Manufacturing licenses of specified drugs
• Blood products
• Vaccines
• Recombinant DNA products
• Operates through CDSCO in coordination with States

f) Drugs Technical Advisory Board (DTAB)

• Highest technical advisory body under Drugs & Cosmetics Act
• Advises CDSCO on:
• Drug standards
• Technical amendments
• Regulatory policies

📌 Exam tip: DTAB = technical, DCC = coordination & uniformity

g) National Pharmaceutical Pricing Authority (NPPA)

• Regulates drug pricing
• Functions:
• Fixes or revises prices of scheduled drugs
• Monitors prices of non-scheduled (decontrolled) drugs
• Implements Drug Price Control Orders (DPCO)

📌 Important correction:
NPPA does NOT approve drugs — it controls prices only.

h) Genetic Engineering Appraisal Committee (GEAC)

(Earlier called Approval Committee; “Appraisal” is the correct term)

• Regulates activities involving:
• Genetic engineering
• GM organisms
• r-DNA products
• Biotech clinical trials involving GM products are:
• Referred by DCGI to GEAC

i) Department of Biotechnology (DBT)

• Functions under Ministry of Science & Technology
• Promotes:
• Biotechnology research
• Infrastructure development
• Translational research
• Funds and supports biotech institutions and programs

📌 Exam note: DBT supports development, not regulatory approvals.

j) Atomic Energy Regulatory Board (AERB)

• Regulates:
• Radiation-emitting equipment
• Nuclear medicine devices
• Radiopharmaceutical safety
• Ensures radiation protection for workers and patients

QUICK EXAM SUMMARY TABLE

Body	Main Role
DCGI	Drug & clinical trial approval
ICMR	Biomedical research & ethics
DCC	Uniform enforcement guidance
DTAB	Technical advisory
CDL	Drug quality testing
CLAA	Central manufacturing approval
NPPA	Drug price control
GEAC	Genetic engineering regulation
DBT	Biotechnology development
AERB	Radiation equipment regulation

k) Bhabha Atomic Research Centre (BARC)

• Premier research institution under the Department of Atomic Energy (DAE).
• Involved in:
• Research and development of nuclear science
• Development of radiopharmaceuticals
• Important clarification (exam-relevant):
  👉 BARC does NOT act as the regulatory approval authority.
  👉 Regulatory control and approval of radiation equipment and radiopharmaceutical use lie with AERB, not BARC.

📌 One-line exam answer:
BARC is a research and development body, while AERB is the regulator.

CLINICAL RESEARCH REGULATIONS IN INDIA

Drug Controller General of India (DCGI)

• DCGI functions under CDSCO
• CDSCO works under the Ministry of Health & Family Welfare
• Enforces the Drugs and Cosmetics Act, 1940 & Rules

Role of DCGI in Clinical Research

• Primary authority for regulating clinical trials in India
• Responsible for:
• Approval of clinical trial protocols
• Approval of new drugs
• Oversight of safety, efficacy, and quality
• Coordinates with:
• Ethics Committees
• Other regulatory bodies (e.g., GEAC for biotech products)

CDSCO – ORGANIZATIONAL STRUCTURE

Head:
➡️ Drugs Controller General of India (DCGI)

1. Headquarters

Functions:

• New drug approval
• CLAA-related approvals
• Import registration
• Coordination with DTAB & DCC

2. Zonal Offices (4)

Functions:

• GMP audits
• Coordination with State Drug Control Authorities
• Enforcement activities

3. Sub-Zonal Offices (2)

Functions:

• GMP inspections
• Sales and distribution surveillance

4. Port Offices (7)

Functions:

• Control of import & export of drugs
• Sampling of imported products

5. Laboratories (6)

Functions:

• Testing of drug samples
• Validation of test protocols
• Quality surveillance support

FUNCTIONS OF CDSCO (EXAM-IMPORTANT)

• Approval of new drugs
• Approval and regulation of clinical trials
• Import registration and licensing
• Licensing of:
• Blood banks
• Large Volume Parenterals (LVPs)
• Vaccines
• r-DNA products
• Selected medical devices

QUICK EXAM DIFFERENTIATION (Very Important)

Body	Primary Role
DCGI	Drug & clinical trial approval
CDSCO	Central drug regulatory authority
BARC	Nuclear & radiopharmaceutical research
AERB	Radiation safety & regulatory approval
GEAC	Genetic engineering & GM products
NPPA	Drug price control

“DCGI approves the drug and the trial, GEAC clears genetic safety, AERB clears radiation safety, and BARC supports research.”

FUNCTIONS UNDER DRUGS & COSMETICS ACT AND RULES (India)

1. Amendment of Drugs and Cosmetics Act & Rules

• Central Government has the authority to:
• Amend the Drugs and Cosmetics Act, 1940
• Amend the Drugs and Cosmetics Rules, 1945
• Amendments are done to:
• Incorporate new technologies
• Harmonize with global guidelines (ICH, WHO)
• Strengthen patient safety and regulatory oversight

2. Banning of Drugs and Cosmetics

• Central Government can prohibit manufacture, sale, or distribution of drugs/cosmetics:
• If found unsafe
• If lacking therapeutic justification
• If quality standards are not met
• Implemented through Gazette notifications

3. Grant of Licenses & NOCs

• Test License
  → For manufacture/import of drugs for:
• Examination
• Test
• Analysis
• Personal License
  → For import of small quantities for personal use
• NOC for Export → Issued by CDSCO for export of drugs not marketed in India

4. Testing of Drugs

• Conducted through:
• Central Drugs Laboratory (CDL)
• CDTLs and State Drug Testing Laboratories
• Purpose:
• Ensure compliance with pharmacopeial standards
• Support enforcement and legal proceedings

CLINICAL TRIAL GUIDELINES IN INDIA

Clinical trials in India are governed by the following regulatory and ethical frameworks:

1. Schedule Y – Drugs & Cosmetics Rules, 1945

• Core legal framework for:
• Clinical trials
• New drug approval
• (Note: Schedule Y is part of the Rules, not the Act)

2. Ethical Guidelines for Biomedical Research on Human Participants

• Issued by ICMR
• First issued in 2000, later revised (2006, 2017)
• Covers:
• Informed consent
• Ethics committee functioning
• Participant protection

3. Good Clinical Practice (GCP) Guidelines

• Issued by CDSCO
• Ensure:
• Ethical conduct
• Scientific validity
• Credibility of clinical trial data

4. Good Laboratory Practice (GLP) Guidelines

• Issued by CDSCO / DBT
• Applicable to:
• Non-clinical safety studies
• Preclinical toxicology studies

5. Bioavailability (BA) & Bioequivalence (BE) Guidelines

• Issued by CDSCO
• Mandatory for:
• Generic drug approval
• Fixed dose combinations (FDCs)

6. National Pharmacovigilance Programme

• Launched in 2004
• Strengthened later as PvPI (Pharmacovigilance Programme of India)
• Purpose:
• Detection
• Assessment
• Prevention of adverse drug reactions

IMPORTANCE OF SCHEDULE Y (HIGH-YIELD)

• Provides regulatory requirements for:
• Import of new drugs
• Manufacture of new drugs
• Conduct of clinical trials
• Defines:
• Phase I–IV trials
• Study design
• Data requirements
• Harmonized with:
• ICH
• USFDA
• WHO-GCP

📌 Exam line:
Schedule Y ensures that Indian clinical trials follow globally accepted scientific and ethical standards.

RULES GOVERNING REGISTRATION OF DRUGS IN INDIA

Rule 122A

• Permission to import a new drug

Rule 122B

• Permission to manufacture a new drug

Rule 122D

• Permission to import or manufacture Fixed Dose Combinations (FDCs)

Rule 122DA

• Permission to conduct clinical trials for new drugs

Rule 122E

• Defines “New Drug” Includes:
• New chemical entity
• New indication
• New dosage form
• New route of administration
• New FDC

APPLICATION FOR PERMISSION TO CONDUCT CLINICAL TRIALS

IND Application

• Sponsor must submit Form 44 to CDSCO
• Same Form 44 is used for:
• Clinical trial permission
• Import of new drug
• Manufacture of new drug

IND CONTENTS (As per Schedule Y)

1.     Chemical & Pharmaceutical Information

• Drug composition
• Stability data
• Manufacturing details

2.     Animal Pharmacology & Toxicology Data

• Acute toxicity
• Repeated dose toxicity
• Reproductive toxicity (if applicable)

3.     Clinical Trial Protocol

• Study design
• Inclusion/exclusion criteria
• Endpoints

4.     Investigator’s Brochure

5.     Ethics Committee approval

6.     Informed Consent Documents

📌 Conceptual link:
IND structure in India is similar to USFDA IND, but governed under Schedule Y.

ONE-LINE EXAM SUMMARY

Clinical trials in India are regulated by Schedule Y, approved by DCGI, ethically guided by ICMR, and monitored through Pharmacovigilance Programme of India.

IND (Investigational New Drug) APPLICATION – INDIA

Additional IND Contents (as shown)

3. Animal toxicology data
4. Regulatory status in other countries (if available)
5. Proposed Phase-I and Phase-II clinical study plans

APPROVAL PROCESS OF IND (India)

Step-wise Flow:

1. IND Applicant (Sponsor)
   ⬇️ submits application
2. CDSCO – Headquarters
   ⬇️
3. Examination by New Drugs Division
   ⬇️
4. Detailed review by IND Committee / Subject Expert Committee (SEC)
   ⬇️
5. Recommendation to DCGI (Drugs Controller General of India)
   ⬇️
6. Final Approval / Rejection

📌 Teaching tip:
DCGI is the final decision-making authority, but decisions are committee-based.

IND REVIEW TIMELINES (As per traditional exam references)

Phase	Timeline
Phase I	90 days
Phase II	45 days
Phase III	60 days

⚠️ Important clarification for students:

• These timelines are classical / exam-oriented values.
• Actual timelines may vary under NDCTR 2019, but exams still ask these numbers.

TYPES OF IND APPLICATIONS IN INDIA

CATEGORY – A (Abbreviated IND)

• Clinical trial protocols already approved in:
• USA, UK, Switzerland
• EU (EMEA/EMA)
• Japan, Australia, Canada
• Germany, South Africa
• Known as Abbreviated INDs
• Fast-track approval
• Approval time: 3–4 weeks

📌 Concept: India relies on prior international regulatory experience.

CATEGORY – B (Regular IND)

• Includes:
• All trials not covered under Category-A
• Most Phase-I clinical trials
• Requires full scientific and regulatory review
• Approval time: 8–12 weeks

📌 Concept: New molecules and first-in-human studies fall here.

QUICK COMPARISON (HIGH-YIELD)

Feature	Category A	Category B
Prior foreign approval	Yes	No
Review type	Abbreviated	Full review
Phase-I trials	Rare	Common
Approval time	3–4 weeks	8–12 weeks

ONE-LINE EXAM ANSWERS

• IND approval in India is granted by DCGI through CDSCO.
• Category-A INDs are fast-tracked based on prior global approvals.
• Category-B INDs undergo full regulatory scrutiny.

“India follows a risk-based IND review system—less review when global data exists, and deeper review for new or first-in-human drugs.”

CLINICAL TRIAL REQUIREMENTS (INDIA)

1. New Drugs Discovered in India

• Clinical trials must be conducted from Phase-I to Phase-III in India.
• Full evaluation of:
• Safety
• Efficacy
• Dose optimization

📌 Reason: No prior human data exists.

2. New Drugs Discovered Outside India

• Phase-I trials are generally not required in India
• Because Phase-I data is already available from abroad
• Exception:
  Phase-I may be allowed if the drug is of special relevance to Indian public health.

3. Acceptance of Foreign Clinical Data

• Safety and efficacy data from other countries may be accepted when:
• Drug is intended for serious or life-threatening diseases
• Indian population relevance is justified
• Bridging studies may still be required.

4. Relaxation of Data Requirements

For drugs indicated for:

• Life-threatening diseases
• Serious illnesses
• Diseases of special relevance to Indian health scenario

➡️ Toxicological and clinical data requirements may be:

• Abbreviated
• Deferred
• Omitted (in exceptional cases)

📌 Examples: Cancer, HIV, TB, rare diseases, pandemics.

ONE-LINE EXAM SUMMARY (INDIA)

India follows a risk-based and public-health-oriented clinical trial approach, allowing flexibility for serious and life-threatening diseases.

DRUG REGULATORY AGENCY IN USA

U.S. FOOD AND DRUG ADMINISTRATION (USFDA)

Nature of FDA

• A scientific, regulatory, and public health agency
• Operates under the Department of Health and Human Services (HHS)

FDA Regulatory Responsibilities

Regulates safety and effectiveness of:

• Human drugs
• Animal drugs
• Biologics
• Medical devices
• Radiation-emitting products
• Food and color additives
• Infant formulas
• Cosmetics
• Animal feed

Scientific Role of FDA

• FDA scientists evaluate:
• New drug applications
• Biologics
• Complex medical devices
• Food & color additives
• Animal drugs

Scope of FDA Oversight

• Monitors:
• Manufacturing
• Import
• Transport
• Storage
• Sale
• Covers products worth ~$1 trillion annually

FDA Leadership

• Headed by the Commissioner of Food and Drugs
• Appointed by:
• President of the United States
• Confirmed by the Senate

CLINICAL RESEARCH REGULATIONS IN USA

NEW DRUG APPROVAL PROCESS (FDA)

1. Pre-IND Meeting

• Informal discussion between Sponsor and FDA
• Purpose:
• Clarify regulatory expectations
• Discuss preclinical data
• Plan clinical development

2. Submission of IND

• Sponsor submits Investigational New Drug (IND) application
• FDA reviews:
• Preclinical safety data
• Clinical trial protocol
• Investigator information

3. End-of-Phase-II Meeting

• Critical decision-making stage
• Purpose:
• Review Phase-II data
• Agree on Phase-III design
• Reduce chances of failure in later stages

4) Accelerated Drug Review

• Applied for drugs intended to:
• Treat serious or life-threatening diseases
• Address unmet medical needs
• Based on:
• Surrogate endpoints
• Early clinical benefit

5) Parallel Track

• Allows early access to investigational drugs for:
• Patients with serious diseases
• Those who cannot enroll in clinical trials
• Commonly used in:
• HIV/AIDS
• Oncology

6) Clinical Hold Decision

• FDA may temporarily suspend or delay a clinical trial if:
• Safety concerns arise
• Insufficient information is provided
• Protocol deficiencies exist

📌 Exam line:
Clinical hold protects patient safety.

7) Notification to Sponsor

• FDA communicates:
• Deficiencies
• Required clarifications
• Additional data needs
• Sponsor must respond before proceeding further.

8) Sponsor / FDA Meetings (Pre-NDA)

• Conducted before NDA submission
• Purpose:
• Confirm completeness of data
• Discuss NDA format and content
• Reduce chances of rejection

9) New Drug Application (NDA)

• Formal request for marketing approval
• NDA contains:
• Preclinical data
• Clinical trial results
• Manufacturing details
• Labeling information

10) Final Meetings with Sponsor

• FDA discusses:
• Remaining issues
• Risk–benefit assessment
• Labeling and post-marketing commitments

11) Permission for Marketing

• FDA grants approval if:
• Drug is safe and effective
• Manufacturing complies with cGMP
• Drug can now be marketed in the USA

12) Post-Marketing Review (Phase-IV)

• Continuous monitoring for:
• Adverse drug reactions
• Rare or long-term effects
• Includes:
• Pharmacovigilance
• Risk management plans

NEW DRUG DEVELOPMENT TIMELINE (USA)

1. Pre-Clinical Research

• Duration: 1–2 years
• Includes:
• In-vitro studies
• Animal testing
• Initial synthesis & purification

2. Clinical Research & Development

• Duration: Up to ~10 years
• Phases:
• Phase I – Safety, dose (healthy volunteers)
• Phase II – Efficacy, dose optimization
• Phase III – Large-scale confirmation

📌 IND undergoes 30-day safety review before human trials begin.

3. NDA Review

• Average duration: ~24 months
• Can range from 2 months to 7 years
• FDA evaluates:
• Benefit–risk profile
• Manufacturing quality
• Labeling accuracy

4. Post-Marketing Surveillance

• Includes:
• Adverse event reporting
• Surveys
• Sampling & testing
• Inspections

REGULATORY ENVIRONMENT IN EUROPE

Regulatory Authority – Europe

European Medicines Agency (EMA)

(Earlier called EMEA – European Medicines Evaluation Agency)

📌 Correct current term: EMA

Role of EMA

• Central regulatory authority for medicines in the European Union
• Responsible for:
• Scientific evaluation
• Supervision
• Safety monitoring of medicines

EMA & Clinical Trials

• Relies on:
• Results of clinical trials conducted by pharmaceutical companies
• Provides scientific opinions on:
• Authorization of medicines
• Final approval granted by:
• European Commission

ONE-LINE EXAM COMPARISON

Region	Authority	Approval Focus
India	DCGI / CDSCO	Public health–based flexibility
USA	FDA	Step-wise scientific rigor
Europe	EMA	Centralized EU authorization

TEACHING CLOSURE LINE

“Drug approval is a global, multi-stage scientific process—FDA focuses on structured rigor, EMA on centralized EU evaluation, and India on public-health-driven flexibility.”

 

REGULATORY ENVIRONMENT IN EUROPE – CLINICAL TRIALS & MARKETING AUTHORISATION

Role of the European Medicines Agency (EMA)

• Authorization of clinical trials is granted at the Member State level (National Competent Authorities).
• However, EMA plays a key coordinating role by:
• Ensuring uniform application of Good Clinical Practice (GCP) across the European Economic Area (EEA)
• Working in cooperation with Member States
• EMA manages the EU clinical trials database
• Current system: CTIS (Clinical Trials Information System)
  (Older exams may still mention “EU Clinical Trials Database”)

📌 Exam note:
Clinical trial approval = national level,
Clinical trial standards & oversight = EMA coordination.

EUROPEAN MEDICINES AGENCY (EMA)

(Earlier called EMEA – European Medicines Evaluation Agency)

• Decentralized agency of the European Union
• Current headquarters: Amsterdam, Netherlands
  ⚠️ London is no longer correct (post-Brexit)

MARKETING AUTHORISATION OF MEDICINES IN THE EU

Medicines in the European Union can be authorised through:

1. Centralized Authorisation Procedure
2. National / Decentralised / Mutual Recognition Procedures

CENTRALIZED AUTHORISATION PROCEDURE

(Community Authorisation Procedure)

• Results in a single marketing authorisation
• Valid in:
• All EU Member States
• EEA countries: Iceland, Liechtenstein, Norway

📌 Term:
This authorisation is called a Community Marketing Authorisation.

MEDICINES FOR WHICH CENTRALIZED PROCEDURE IS COMPULSORY

1) Biotechnology-derived medicines

• Products obtained by:
• Genetic engineering
• Recombinant DNA technology
• Hybridoma technology

2) Medicines intended for treatment of:

• HIV / AIDS
• Cancer
• Diabetes
• Neurodegenerative disorders
• Autoimmune diseases & immune dysfunctions

3) Orphan Medicines

• Medicines for rare diseases
• Officially designated as orphan drugs

📌 Exam line:
Centralized procedure is mandatory for biotech and orphan medicines.

OPTIONAL USE OF CENTRALIZED PROCEDURE

For medicines not falling under the mandatory scope, companies may still apply via the centralized route if:

• The medicine represents:
• Significant therapeutic innovation
• Scientific or technical advancement
• Or if authorization is:
• In the interest of public health

APPLICATION & EVALUATION PROCESS (CENTRALIZED PROCEDURE)

• Application is submitted directly to EMA
• Evaluation performed by EMA’s Scientific Committees
  (mainly CHMP – Committee for Medicinal Products for Human Use)

Evaluation Timeline

• Maximum: 210 days
• (Clock stops may occur when additional data is requested)

FINAL AUTHORISATION

• EMA issues a scientific opinion
• Opinion is forwarded to the European Commission
• European Commission grants the final marketing authorisation

📌 Exam point:
EMA → Scientific opinion
European Commission → Legal approval

POST-AUTHORISATION

• Once a Community Marketing Authorisation is granted:
• Marketing authorisation holder can:
• Market the medicine
• Supply it to patients and healthcare professionals
• Valid across all EU/EEA countries

ONE-PAGE EXAM SUMMARY

Aspect	Key Point
Clinical trial approval	Member States
GCP harmonization	EMA
EU trial database	CTIS
Centralized approval	EMA + European Commission
Timeline	210 days
Validity	EU + EEA
HQ of EMA	Amsterdam

TEACHING CLOSURE LINE

“In Europe, Member States authorize trials, EMA harmonizes standards, and the European Commission grants marketing approval.”

 

NATIONAL AUTHORISATION PROCEDURES (EU)

• Each EU Member State has its own national procedure for authorising medicinal products outside the scope of the centralized procedure.
• These authorisations are valid only within that Member State’s territory.
• Information on national procedures is available on:
• Websites of the National Competent Authorities (NCAs)
• Heads of Medicines Agencies (HMA) website (useful central entry point)

ROUTES FOR AUTHORISATION IN MULTIPLE EU COUNTRIES

(For products outside mandatory centralized scope)

(A) DECENTRALISED PROCEDURE (DCP)

• Used when:
• The medicinal product has not yet been authorised in any EU Member State
• The product does not fall under mandatory centralized procedure
• Companies apply simultaneously to multiple EU countries.
• One country acts as:
• Reference Member State (RMS)
• Other participating countries are:
• Concerned Member States (CMS)

📌 Key exam line:
DCP = Simultaneous first-time authorisation in multiple EU countries

(B) MUTUAL RECOGNITION PROCEDURE (MRP)

• Used when:
• A medicine is already authorised in one EU Member State
• That country becomes the:
• Reference Member State (RMS)
• Other EU countries:
• Recognise the existing national authorisation
• Leads to national marketing authorisations in additional countries.

📌 Key exam line:
MRP = First national approval → then recognition by other states

QUICK COMPARISON: DCP vs MRP

Feature	DCP	MRP
Prior authorisation	❌ No	✅ Yes (one country)
First approval	Simultaneous	National first
RMS involved	Yes	Yes
Centralized mandatory?	No	No

GOOD CLINICAL PRACTICE (GCP) – HUMAN MEDICINAL PRODUCTS

Legal Framework (UPDATED)

• Requirements for clinical trials in the EU were originally implemented through:
• Clinical Trials Directive (2001/20/EC) ⚠️ now repealed
• Current governing law:
• EU Clinical Trials Regulation (EU) No. 536/2014
• Applies across the European Economic Area (EEA).

📌 Exam tip:
Directive = old
Regulation 536/2014 = current and directly applicable

GCP REQUIREMENTS

• All clinical trials included in marketing authorisation applications in the EEA must:
• Be conducted in accordance with Good Clinical Practice (GCP)
• GMP requirements apply to:
• Investigational Medicinal Products (IMPs)
• Inspections are conducted to verify compliance with:
• GCP
• GMP (for clinical trials)

VOLUME 10 – EU RULES FOR CLINICAL TRIALS

• Volume 10 of The Rules Governing Medicinal Products in the EU covers:
• Clinical trial authorisation
• Safety reporting
• GCP inspections
• GCP and GMP requirements
• Applies to trials conducted in the EEA

ICH GCP ADOPTION IN EUROPE

• Europe adopted ICH-GCP (E6) in July 1996
• ICH-GCP is:
• Binding for clinical trials used in EU regulatory submissions
• Published and maintained through EMA resources

📌 Common MCQ:
ICH-GCP adopted in Europe → 1996

GCP INSPECTORS WORKING GROUP (EMA)

• EMA relies on Member State GCP inspectors for:
• Inspection planning
• Conduct
• Reporting
• Coordination is achieved through the:
• GCP Inspectors Working Group

Composition & Meetings

• Members:
• GCP inspectors from EEA Member States
• Observers from:
• Candidate countries
• Switzerland
• Meetings:
• Regularly (typically 4 times per year)
• Held at EMA (Amsterdam)

ROLE OF GCP INSPECTORS WORKING GROUP

• Develops harmonised procedures for:
• Coordination of inspections
• Preparation and conduct of inspections
• Reporting of inspection outcomes
• Especially important for:
• Centralized marketing authorisation procedure

EXAM-READY SUMMARY (VERY IMPORTANT)

• National authorisation → Single country
• DCP → Simultaneous first approval in multiple countries
• MRP → Recognition of existing national approval
• GCP legal basis → EU Regulation 536/2014
• ICH-GCP adopted → 1996
• GCP inspections → Coordinated by EMA via inspectors working group

ONE-LINE MEMORY AID

Centralized = EMA + Commission
DCP = parallel first approvals
MRP = recognise existing approval