Pharmaceuticals, General Survey
Authors: McGuire John L. , Hasskarl Horst , Bode Gerd , Klingmann Ingrid , Zahn Manuel 
Published: April 2007

The article contains sections titled:

1.

Introduction

2.

Companies, Markets, and Products

3.

Legal Requirements and Guidance

3.1.

General

3.2.

Definitions

3.3.

Requirements Relating to the Development of Pharmaceutical Products

3.4.

Marketing Approval

3.5.

Requirements for the Manufacture and Quality Control of Pharmaceutical Products

3.6.

Requirements for the Placing of a Pharmaceutical Product on the Market

3.7.

Liability

3.8.

International Non‐Proprietary Names (INN)

4.

Development of Pharmaceutical Products

4.1.

Preclinical Safety/Toxicology

4.1.1.

Preclinical Safety

4.1.2.

Toxicological Strategies

4.1.3.

ICH Guidelines for Carcinoginicity

4.1.4.

ICH Guidelines for Genotoxicity (ICH S2A and ICH S2B)

4.1.5.

ICH Guidelines for Toxicokinetics/Pharmacokinetics (ICH S3A and ICH S3B)

4.1.6.

ICH Guidelines for Reproductive Studies (ICH S5A and ICH S5B)

4.1.7.

Preclinical Safety Evaluation of Biotechnology‐Derived Products (ICH S6)

4.1.8.

Safety Pharmacology Studies for Human Pharmaceuticals (ICH S7A)

4.1.9.

Nonclinical Studies for Assesing Risk of Repolarization‐Associated Ventricular Tachyarrhythmia for Human Pharmaceuticals (ICH S7B)

4.1.10.

Immunotoxicology Studies (ICH S8)

4.1.11.

Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (ICH M3)

4.1.12.

Inclusion of Special Populations (ICH M3)

4.1.13.

The Common Technical Document (ICH M4)

4.2.

Clinical Trials

4.2.1.

Phases of Clinical Drug Development

4.2.2.

Methods for Proving Effectiveness

4.2.3.

Adverse Drug Reactions

4.2.4.

Good Clinical Practice

4.2.5.

Clinical Application Dossier

4.3.

Quality of Pharmaceutical Products

4.3.1.

Manufacturing of Substances ‐ Test of Starting Materials

4.3.2.

Control of Active Substances: Impurities

4.3.3.

Control of Pharmaceutical Products: Impurities

4.3.4.

Specifications

4.3.5.

Validation of Analytical Procedures

4.3.6.

Process Validation and Qualification

4.3.7.

Batch Release

4.3.8.

Stability Testing

4.3.9.

Documentation

4.3.10.

Variations ‐ Changes

4.3.11.

Change Control

4.3.12.

Compliance

4.3.13.

Changes Requiring New Applications ‐ Line Extension

4.3.14.

Inspections

4.3.15.

The Mutual Recognition Agreement (MRA)

4.3.16.

Pharmaceutical Inspection Convention (PIC)

4.3.17.

Pharmaceutical Inspection Cooperation Scheme (PIC/S)

4.3.18.

Pharmacopeias

4.3.19.

The EP Certificate of Suitability

Pharmaceutical products are among the most efficient forms of therapeutic agents. Most of these active substances are based on small organic molecules, which are designed and developed in the research and development laboratories of the pharmaceutical industry. This industry is heavily regulated in terms of requiring regulatory approval to market medicinal products and, in many countries, requiring price approvals. There exists a complex interaction with the medicinal profession, governments, and insurance groups. A comprehensive national legal framework exists to avoid risks in connection with the development, manufacture, distribution, and use of medicines.