Pilot Project II - Information Board

Regulatory information in various categories, partly in Spanish.

1.Regulatory Guidelines and Legislation

1.1 Medicamentos de uso humano

1.1.1 Reglamento (CE) N° 726/2004 del Parlamento Europeo y del Consejo, de 31 de marzo de 2004, por el que se establecen procedimientos comunitarios para la autorización y el control de los medicamentos de uso humano y veterinario y por el que se crea la Agencia Europea de Medicamentos.
El presente Reglamento tiene por objeto el establecimiento de procedimientos comunitarios para la autorización, el control y la farmacovigilancia en lo relativo a los medicamentos de uso humano y veterinario, así como la creación de una Agencia Europea de Medicamentos.

1.1.2 Directiva 2004/27/CE del Parlamento Europeo y del Consejo, de 31 de marzo de 2004, que modifica la Directiva 2001/83/CE por la que se establece un código comunitario sobre medicamentos de uso humano.
Las disposiciones de la presente Directiva se aplicarán a los medicamentos para uso humano producidos industrialmente y destinados a ser comercializados en los Estados miembros.

1.1.3 Real Decreto 1345/2007, de 11 de octubre, por el que se regula el procedimiento de autorización, registro y condiciones de dispensación de los medicamentos de uso humano fabricados industrialmente.
Este real decreto tiene por objeto regular los medicamentos de uso humano fabricados industrialmente y en particular:
a) Los requisitos de la solicitud para la autorización de comercialización.
b) Los procedimientos de autorización, suspensión y revocación de la autorización, así como de las modificaciones de las condiciones de autorización.
c) La ficha técnica, el etiquetado y prospecto.
d) Las condiciones particulares para determinadas clases de medicamentos.
e) Las obligaciones del titular.
f) Los procedimientos comunitarios.
g) La inscripción en el registro de medicamentos, incluidos los medicamentos especiales regulados en el capítulo IV.

1.1.4 Notice to Applicants: EudraLex - Volume 2 - Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use | Public Health (europa.eu).
Volume 2 of the publications "The rules governing medicinal products in the European Union" contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics (SmPC), package information and classification for the supply, readability of the label and package leaflet requirements.
The linked Notice to Applicants has been prepared by the European Commission, in consultation with the competent authorities of the Member States and the European Medicines Agency (EMA). This Notice has no legal force and does not necessarily represent the final views of the Commission. In case of doubt, therefore, reference should be made to the appropriate Union Directives and Regulations.
The Notice to Applicants was first published in 1986 and is regularly updated.

  • Volume 2A - Procedures for marketing authorisation
  • Volume 2B - Presentation and content of the dossier

1.1.5 Real Decreto Legislativo 1/2015, de 24 de julio, por el que se aprueba el texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios.
Esta ley regula, en el ámbito de las competencias que corresponden al Estado:
a) Los medicamentos de uso humano y productos sanitarios. La regulación también se extiende a las sustancias, excipientes y materiales utilizados para su fabricación, preparación o envasado.
b) La actuación de las personas físicas o jurídicas en cuanto intervienen en la circulación industrial o comercial y en la prescripción o dispensación de los medicamentos y productos sanitarios.
c) Los criterios y exigencias generales aplicables a los medicamentos veterinarios.
d)  Los cosméticos y productos de cuidado personal.

1.2 Ensayos clínicos

2.1.1 Real Decreto 1090/2015, de 4 de diciembre, por el que se regulan los ensayos clínicos con medicamentos, los Comités de Ética de la Investigación con medicamentos y el Registro Español de Estudios Clínicos.
Este real decreto se aplicará a los ensayos clínicos con medicamentos de uso humano que se realicen en España y tiene por objeto:
a) Desarrollar las disposiciones específicas para la aplicación en España del Reglamento (UE) n.° 536/2014 del Parlamento Europeo y del Consejo, de 16 de abril de 2014, sobre los ensayos clínicos de medicamentos de uso humano, y por el que se deroga la Directiva 2001/20/CE, relativas a los ensayos clínicos con medicamentos de uso humano que se realicen en España.
b) Regular los Comités de Ética de la Investigación con medicamentos, así como el Registro español de estudios clínicos.

 

2.1.2 Reglamento (UE) No 536/2014 del Parlamento Europeo y del Consejo, de 16 de abril de 2014, sobre los ensayos clínicos de medicamentos de uso humano, y por el que se deroga la Directiva 2001/20/CE.
Detalla los requisitos y características aplicables a los ensayos clínicos con medicamentos de uso humano realizados en la Unión Europea.

1.3 Orphan Medicines for Rare diseases

3.1.1 Orphan Designation at a glance.
About 30 million people living in the European Union (EU) suffer from a rare disease. The European Medicines Agency (EMA) plays a central role in facilitating the development and authorisation of medicines for rare diseases, which are termed 'orphan medicines' in the medical world.

3.1.2 Orphan Designation: Research and development.
The European Medicines Agency provides support, including regulatory guidance and incentives, for the research and development of medicines for rare diseases in the European Union (EU). The following page lists the questions that sponsors may have on applying for orphan designation: Questions and answers: Orphan-designation application | European Medicines Agency (europa.eu)

3.1.3 Guía rápida para el desarrollo de medicamentos huérfanos para enfermedades raras.
Guía para investigadores acerca de los medicamentos huérfanos para enfermedades raras.

3.1.4 Orpharsefh.
Grupo de trabajo de Enfermedades Raras y Medicamentos Huérfanos de la SEFH.

Link to the Repurposing Pilot

2. Quality Guidelines (Chemistry)

2.1 Nanomedicines

2.1.1 Reflection paper on data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product.
This reflection paper discusses the data requirements for nano-sized colloidal intravenous iron-based preparations developed as a treatment for iron deficiency with reference to an innovator product.

2.1.2 Reflection paper on data requirements for intravenous liposomal products developed with reference to an innovator liposomal product.  
This document discusses the principles for assessing liposomal products developed with reference to an innovator liposomal product but does not aim to prescribe any particular quality, nonclinical or clinical strategy.

2.1.3 Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products.
This reflection paper discusses the general principles for assessing block copolymer micelle products but does not aim to prescribe any particular quality, non-clinical or clinical strategy.

2.1.4 Surface coatings: general issues for consideration regarding parenteral administration of coated nanomedicine products.
This paper highlights issues that require consideration during the development and lifecycle of coated nanomedicine products designed for parenteral administration.
It should be read in connection with the following documents:

  • Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator product EMA/CHMP/SWP/100094/2011.
  • Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product EMA/CHMP/806058/2009/Rev. 02.
  • Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products EMA/CHMP/13099/2013.

2.1.5 First International Workshop on Nanomedicines - 2010 Summary Report.
The present report includes summaries of the speakers’ presentations and the discussions that took place at the workshop. The speakers’ presentations can be found in the linked document.

2.2 General documents to take into account to support

2.2.1 Quality: pharmaceutical development.
The European Medicines Agency's scientific guidelines on pharmaceutical development help medicine developers prepare marketing authorisation applications for human medicines.

2.2.1.1 Quality requierements for drug-device combinations.
Guidance is provided on dossier requirements for drug-device combinations (DDCs) in the context of a regulatory submission (marketing authorisation application and post-authorisation application). The types of DDCs within the scope of this guideline are medical devices that are integral to the medicinal product, co-packaged with the medicinal product or referenced in the medicinal product information and obtained separately.

2.2.1.2 Development pharmaceutics.
This document provides guidance on the data from pharmaceutical development studies required for marketing authorisation. Read together with the 'Guideline on the sterilization of the medicinal product, active substance, excipient and primary container'.

2.2.1.3 ICH Q8 Pharmaceutical development.
This document describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches.

2.2.1.4 ICH Q9 Quality risk management.
This document provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products.

2.2.1.5 ICH Q10 Pharmaceutical quality system.
This document describes a model for an effective quality management system. It applies to the development and manufacture of pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.

2.2.1.6 ICH Q8, Q9 and Q10- questions and answers.
This document provides guidance on the implementation of ICH guidelines Q8, Q9 and Q10. It answers the questions about the current procedure of the ICH Quality Implementation Working Group on those guidelines.

2.2.1.7 Pharmaceutical development of medicines for paediatric use.
This document provides guidance on the pharmaceutical development of medicinal products for children between birth and 18 years of age.

2.2.1.8 Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorization applications.
This guidance summarises scientific and regulatory approaches that developers of medicines supported by EMA’s PRIME scheme can use to generate robust quality data for an EU marketing authorisation application, to enable patients to benefit from these therapies as early as possible. It covers medicines containing chemical, biological or biotechnologically derived substances and advanced therapy medicinal products (ATMPs).

2.2.2 Quality Guidelines.
The European Medicines Agency's scientific guidelines on the quality of human medicines help applicants prepare marketing authorisation applications. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.

2.2.3 ICH guidelines.
Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

2.2.3.1 ICH M4Q. Location issues for Common Technical Document for the Registration of Pharmaceuticals for Human Use – Quality Questions and Answers.
This document is intended to provide additional guidance for the preparation of an application file in the CTD-Q format.

3. Quality Guidelines (Biologics)

3.1 Organismos Modificados Genéticamente (OMG)

3.1.1 Guía práctica para la remisión de solicitudes de liberación voluntaria para llevar a cabo ensayos con medicamentos que consistan o contengan organismos modificados genéticamente.
El objetivo de esta guía es proporcionar directrices a toda persona que se proponga realizar una liberación voluntaria de Organismos Modificados Genéticamente (OMG) distintos de plantas en el contexto de un ensayo clínico con medicamentos de uso humano o veterinario y, en concreto, en relación con la información que deberían suministrar a efectos de solicitar una autorización para la realización de dicha liberación voluntaria.

3.2 Requirements in clinical trials

3.2.1 Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials.
The scope of this guideline addresses the specific documentation requirements on the biological, chemical and pharmaceutical quality of IMPs containing biological / biotechnology derived substances (proteins and polypeptides).

3.2.2 Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials.
The guideline provides guidance on the structure and data requirements for a clinical trial application for exploratory and confirmatory trials with advanced therapy investigational medicinal products (ATIMPs). It addresses development, manufacturing and quality control as well as non-clinical and clinical development of ATIMPs.

3.3 Virus safety evaluation

3.3.1 Guideline on virus safety evaluation of biotechnological investigational medicinal products.
The purpose of this document is to provide scientific guidance to the viral safety of biotechnological medicinal products used in clinical trials. It applies to human biotechnological IMPs prepared from cells cultivated in vitro from characterised cell banks of human / animal origin (ICH Q5A).

3.4 Advance Therapy Medicinal Products (ATMPs)

3.4.1 Guidelines relevant for advanced therapy medicinal products.
The European Medicines Agency develops scientific guidelines to help pharmaceutical companies and individuals to prepare marketing-authorisation applications for human medicines. This page lists relevant guidelines for applicants for advanced therapy medicinal products: gene therapy medicinal products and cell-therapy and tissue engineering.

3.4.2 Scientific recommendations on classification of advanced therapy medicinal products.
The European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT) delivers scientific recommendations on whether a medicine can be classified as an advanced therapy medicinal product (ATMP).

4. Planning of Clinical Trials

4.1 Instrucciones de la AEMPS para la realización de ensayos clínicos en España

En el presente documento de instrucciones de la Agencia Española de Medicamentos y Productos Sanitarios para la realización de ensayos clínicos en España se proporciona, en un formato de preguntas y respuestas, información sobre los aspectos prácticos que conlleva la aplicación del nuevo real decreto resaltando los cambios respecto al real decreto previo.

4.2 Types of clinical trials

4.2.1 Conventional Clinical Trials

4.2.1.1 Clinical Trials Regulation (EU) No 536/2014 – Q&A document. The rules of governing medicinal products in the European Union VOLUME 10 – Guidance documents applying to clinical trials.

  • Section 5. Sponsor/Legal representative; investigator.  The functions, characteristics and requirements of the sponsor are detailed, as well as what the protocol synopsis should contain.
  • Section 11. Arrangements for the transitional period. The conditions for the changeover to the new Clinical Trial Regulation are detailed, as well as the different existing procedures (e.g. VHP (Voluntary Harmonisation Procedure)) for the different types of clinical trials (mono-national and multinational).

4.2.1.2 Eudralex volume 10.
Volume 10 of the publication 'The rules governing medicinal products in the European Union' contains guidance documents applying to clinical trials.

4.2.2 Complex Clinical Trials

4.2.2.1 Recommendation paper on the Initiation and Conduct of Complex Clinical Trial.
This document provides recommendations for sponsors regarding the authorisation and conduct of complex clinical trials. It highlights differences between complex clinical trials and conventional clinical trials particularly with regard to clinical trial applications (CTAs) and requests for substantial amendments.

4.2.3 Multinational Clinical trials

4.2.3.1 Transition of Clinical Trials to Regulation (EU) No. 536/2014: CTFG Best Practice Guide for sponsors of multinational clinical trials with different protocol versions approved in different Member States under Directive 2001/20/EC that will transition to Regulation (EU) No. 536/2014.
It defines the limits of what is acceptable within the same consolidated protocol for transitioning multinational trials with protocols that are not harmonised across Member States and it develops guidance on the best practices to be followed by sponsors when the protocol is not fully harmonised.

4.3 ICH Efficacy Guidelines

4.3.1 ICH E6: Guideline for Good Clinical Practice (GCP).
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

4.3.2 ICH E8: General considerations for clinical trials.
It is intended to:

  • Describe internationally accepted principles and practices in the conduct of both individual clinical trials and overall development strategy for new medicinal products.
  • Facilitate the evaluation and acceptance of foreign clinical trial data.

4.3.3 ICH E10: Choice of control group and related issues in clinical trials.
The purpose of this guideline is to describe the general principles involved in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment and to discuss related trial design and conduct issues.

4.4 Contraception and pregnancy testing

4.4.1 Recommendations related to contraception and pregnancy testing in clinical trials.
The aim of this document is to supplement existing guidelines related to embryofetal risk mitigation and to provide practical guidance on contraception use and pregnancy testing in clinical trials.

4.5 Reference Safety Information (RSI)

4.5.1 Reference Safety Information (RSI) for a Clinical Trial.
It details where and how RSI should be included depending on the different situations: new clinical trial application, ongoing clinical trial or making changes during a clinical trial.

4.5.2 Q&A document – Reference Safety Information.
Q&A document on Reference Safety Information (RSI) updated by the CTFG following detailed discussions between national competent authorities and sponsors, which arose from Clinical Trial application and substantial amendment procedures as well as GCP inspections.

4.5.3 CTFG RSI Q&A cover note.
The CTFG Reference Safety Information Q&A document published on the CTFG website on the 12th of November 2017 (version 1.0). The document was developed to provide clarity to sponsors about the expectations of EU national competent authorities in relation to the RSI for determination of SUSARs (Suspected Unexpected Serious Adverse Reaction) for expedited reporting and annual safety reporting in clinical trials.

4.5.4 Clinical Trials Regulation (EU) No 536/2014 – Q&A document. The rules of governing medicinal products in the European Union VOLUME 10 – Guidance documents applying to clinical trials.
It is important to take into account:

  • Section 7. Safety reporting. The different types of adverse events and adverse reactions, as well as their differences, and the RSI are detailed.

4.6 Data Monitoring

4.6.1 Questions and answers on Data Monitoring Committees issues.
The aim of this question-and-answer (Q&A) document is to supplement the CHMP Guideline on Data Monitoring Committee (EMEA/CHMP/EWP/5872/03 Corr) by providing clarification on:

  • The role and necessity for a Data Monitoring Committee (DMC) in different phases of drug development and throughout the product lifecycle
  • The responsibilities for implementing DMC decisions.

4.6.2 Guideline on Data Monitoring Committees.
This guideline document deals with independent Data Monitoring Committees. It is intended as an overview guide. While confirmatory, double blind, randomised clinical trials are in the focus of this guideline, the general principles outlined in this document also apply to other clinical trial situations.

4.7 FIH and early clinical trials with IMPs

4.7.1 Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.
The revision is intended to further assist stakeholders in the transition from non-clinical to early clinical development and in identifying factors influencing risk for new investigational medicinal products (IMPs).
The document includes considerations on quality aspects, non-clinical and clinical testing strategies, study design and on conduct of FIH / early clinical trials (CTs). It also includes principles on the calculation of the starting dose to be used in humans, the subsequent dose escalations, the criteria for maximum dose and the conduct of the trial inclusive of multiple parts. 

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4.8 Advanced Therapy Medicinal Products (ATMPs)

4.8.1 Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products.
The aim of this guideline is to provide the guidance for the Safety and Efficacy (S&E) follow-up and risk management for advanced therapy medicinal products (ATMPs) according to Article 14(4) of Regulation (EC) No 1394/2007. This guideline provides dedicated and specific guidance for ATMPs with regards to the pharmacovigilance system, the identification of risks, the risk minimisation measures, the post-authorisation S&E studies, the management and the reporting of adverse reactions and of the evaluation of the effectiveness of the risk management system.

4.9 Auxiliary Medicinal Products

4.9.1 Auxiliary Medicinal Products in Clinical Trials.
To have a common understanding of the definitions and requirements of an investigational medicinal product (IMP) and an auxiliary medicinal product (AxMP) administered to subjects in clinical trials.

4.10 COVID-19

4.10.1 Guidance on the management of Clinical Trials during the COVID-19 (coronavirus) pandemic.
The points mentioned in this guideline are intended to provide guidance and clarity for all parties involved in clinical trials during this time. This document sets out to include most of the current guidance across Member States with the aim of serving as a harmonised EU-level set of recommendations. It is complemented by the national guideline in questions 60-62 of the following document:
Documento de instrucciones de la Agencia Española de Medicamentos y Productos Sanitarios para la realización de ensayos clínicos en España (aemps.gob.es)

5. Non-clinical Guidelines

5.1 Nanomedicines

5.1.1 Reflection paper on non-clinical studies for generic nanoparticle iron medicinal product applications.
This paper provides a brief overview about the characteristics to be taken into account and the non-clinical studies to be carried out in order to compare, mainly, some pharmacokinetic and toxicological parameters between the reference and generic nanoparticle-based products (especially nanoparticle iron medicine products (NPI) for parenteral use). The importance of quantifying the concentration of total iron and of the product in the most relevant compartments (plasma, reticuloendothelial system (RES) and target tissue) is stressed.

5.2 Bases legales

5.2.1 Real Decreto 118/2021, de 23 de febrero, por el que se modifica el Real Decreto 53/2013, de 1 de febrero, por el que se establecen las normas básicas aplicables para la protección de los animales utilizados en experimentación y otros fines científicos, incluyendo la docencia.
El objetivo del presente RD es establecer las normas aplicables para la protección de los animales utilizados, criados o suministrados con fines de experimentación y otros fines científicos, incluyendo la educación y docencia. Para ello, regula el principio de las 3Rs (reemplazo, reducción y refinamiento), las condiciones aplicables a los animales, las actividades de los usuarios y la evaluación y autorización de proyectos que hayan empleado animales.

5.2.2 Directiva 2010/63/UE del Parlamento Europeo y del Consejo, de 22 de septiembre de 2010, relativa a la protección de los animales utilizados para fines científicos.
La presente Directiva establece medidas para la protección de los animales utilizados con fines científicos o educativos. Se aplicará cuando se haya previsto utilizar animales en los procedimientos o se críen animales específicamente para que sus órganos o tejidos puedan utilizarse con fines científicos.

5.3 Principles of 3Rs

5.3.1 Guideline on the Principles of Regulatory Acceptance of 3Rs (Replacement, Reduction, Refinement) Testing Approaches.

  • Replacement. Testing approaches that avoid or replace the use of live animals in an experiment where they would have otherwise been used. Replacement could include the use of established animal and human cell lines, or cells and tissues or mathematical and computer models or physicochemical methods.
  • Reduction. Approaches that minimise the number of animals used per experiment or study, either by enabling researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals, thereby avoiding further animal use. Examples include improved experimental design and statistical analysis, combination of studies, international harmonisation of testing requirements (e.g. (V)ICH) to avoid duplicate testing and the use of technologies, such as imaging, to enable longitudinal studies in the same animals.
  • Refinement. Approaches that minimise the pain, suffering, distress or lasting harm that may be experienced by the animals. Refinement applies to all aspects of animal use, from the housing and husbandry used to the scientific procedures performed on them. An example of refinement is the use of appropriate anaesthetics and analgesics.

5.4 Documentación no clínica para ensayos clínicos

5.4.1 Guía de la Agencia Española de Medicamentos y Productos Sanitarios para la presentación de documentación no clínica para la realización de ensayos clínicos.
Se detallan los principios fundamentales a tener en cuenta para la preparación de la parte referente a los datos no clínicos en el Expediente de Medicamento en Investigación y manual del investigador.

5.5 ICH Guidelines

5.5.1 Safety Guidelines.
ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity.  A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.

6. Clinical Guidelines

6.1 Scientific guidelines

The European Medicines Agency's Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for human medicines. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.

Every researcher who wants to develop a medicinal product should take into account the therapeutic indication for which the medicinal product will be authorised.

6.1.1 Clinical efficacy and safety: clinical pharmacology and pharmacokinetics.
The European Medicines Agency's scientific guidelines on clinical pharmacology and pharmacokinetics help medicine developers prepare marketing authorisation applications for human medicines.

6.1.2 Clinical efficacy and safety guidelines.
The European Medicines Agency's scientific guidelines on the clinical efficacy and safety of human medicines help applicants prepare marketing authorisation applications. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.

6.1.2.1 Clinical efficacy and safety: general.
The European Medicines Agency's scientific guidelines on the clinical safety and efficacy help medicine developers prepare marketing authorisation applications for human medicines.

6.1.2.2 Clinical efficacy and safety: alimentary tract and metabolism.
The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used in conditions affecting the gut and metabolism help medicine developers prepare marketing authorisation applications.

6.1.2.3 Clinical efficacy and safety: blood and blood-forming organs.
The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used in conditions affecting the blood and blood-forming organs help medicine developers prepare marketing authorisation applications.

6.1.2.4 Clinical efficacy and safety: blood products (including biotech alternatives).
The European Medicines Agency's scientific guidelines on the clinical evaluation of blood products help medicine developers prepare marketing authorisation applications for human medicines.

6.1.2.5 Clinical efficacy and safety: cardiovascular system.
The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used in conditions affecting the cardiovascular system help medicine developers prepare marketing authorisation applications.

6.1.2.6 Clinical efficacy and safety: dermatologicals.
The European Medicines Agency's scientific guidelines on the clinical evaluation of dermatologicals help medicine developers prepare marketing authorisation applications for human medicines.

6.1.2.7 Clinical efficacy and safety: genitourinary system and sex hormones.
The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used in conditions affecting the genitourinary system and sex hormones help medicine developers prepare marketing authorisation applications.

6.1.2.8 Clinical efficacy and safety: anti-infectives for systemic use.
The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used to treat or prevent infections help medicine developers prepare marketing authorisation applications.

6.1.2.9 Clinical efficacy and safety: antineoplastic and immunomodulating agents.
The European Medicines Agency's scientific guidelines on the clinical evaluation of antineoplastic and immunomodulating agents help medicine developers prepare marketing authorisation applications.

6.1.2.10 Clinical efficacy and safety: rheumatology/musculoskeletal system.
The European Medicines Agency's scientific guidelines on clinical evaluation of human medicines used in disorders affecting the joints, bones, muscles and soft tissues help medicine developers prepare marketing authorisation applications.

6.1.2.11 Clinical efficacy and safety: nervous system.
The European Medicines Agency's scientific guidelines on the clinical evaluation of medicines used in nervous-system disorders help medicine developers prepare marketing authorisation applications for human medicines.

6.1.2.12 Clinical efficacy and safety: respiratory system.
The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used in conditions affecting the lungs and airways help medicine developers prepare marketing-authorisation applications.

6.1.2.13 Clinical efficacy and safety: radiopharmaceuticals and diagnostic agents.
The European Medicines Agency's scientific guidelines on radiopharmaceuticals and diagnostic agents help medicine developers prepare marketing authorisation applications for human medicines.

6.1.2.14 Clinical efficacy and safety: allergy/immunology.
The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used for allergies and related diseases of the immune system help medicine developers prepare marketing-authorisation applications.

6.1.2.15 Biostatistics.
The European Medicines Agency's scientific guidelines on biostatistics help medicine developers prepare marketing authorisation applications for human medicines.

6.2 ICH Guidelines

6.2.1 Efficacy Guidelines.
The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials.  It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics / pharmacogenomics techniques to produce better targeted medicines.


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