The guidelines contained in the following pdf-files, correspond to the date indicated in the document itself. Even though, we try to make the latest version of each guideline available to you, we can neither guarantee correct reproduction of the contents nor that the guidelines indicated meet with the currently latest version.

1. General
1.1. Excipients in the label and package leaflet of medicinal products for human use.pdf (42,8KB)
1.2. Fixed combination medicinal products.pdf (30,9KB)

2. Preclinical
2.1. Pre-clinical biological safety testing on medicinal products derived from biotechnology.pdf (49,9KB)
2.2. The need for carcinogenicity studies of pharmaceuticals.pdf (26,2KB)

3. Clinical
3.1. General
3.1.1 Assessing the efficacy and safety of immunoglobulin products.pdf (51KB)
3.1.2 Investigation of bioavailability and bioequivalence.pdf (154KB)
3.1.3 Pharmacokinetic studies in man.pdf (28KB)
3.1.4 Population exposure long term treatment non-life-threatening.pdf (47KB)
3.1.5 Structure and content of clinical study reports.pdf (34KB)
3.1.6 Biostatistical methodology in clinical trials.pdf (31KB)
3.1.7 Clinical investigation of medicinal products for long-term-use.pdf (58KB)
3.1.8 Clinical investigation of medicinal products in children.pdf (72KB)

3.1.9

Clinical investigation of medicinal products in geriatrics.pdf (221KB)
3.1.10 Clinical requirements for locally applied, locally acting products, containing known constituents.pdf (65KB)
3.1.11 Clinical testing of prolonged action forms.pdf (40KB)
3.1.12 Dose response information to support product authorisation.pdf (26KB)
3.1.13 Good Clinical Practice.pdf (208KB)
3.1.14 EU clinical trial Directive GCP 2001.pdf (152KB)
3.2 Oncology
3.2.1 Clinical trials with haematopoietic growth factors for prophylaxis.pdf (26KB)
3.2.2 Evaluation of anticancer medicinal products in man.pdf (26KB)
3.3 Safety
3.3.1 Clinical safety data management periodic safety update for marketed products.pdf (92KB)
3.3.2 Clinical safety data management definitions and standards for expedited reporting.pdf (57KB)
3.3.3 Pharmacovigilance annex.pdf (31KB)
3.3.4 Rapid alert system in pharmacovigilance.pdf (25KB)

4. Production
4.1 European drug master file procedure for active substances.pdf (50,5KB)
4.2 Stability testing of new active substances and medicinal products.pdf (61KB)
4.3 Stability testing on active ingredients and finished products.pdf (54KB)
4.4 Use of transgenic animals in the manufacture of biologicals.pdf (41KB)
4.5 Validation of virus removal inactivation procedures choice of viruses.pdf (53KB)
4.6 Virus validation studies removal inactivation.pdf (63KB)
4.7 Gene therapy product quality aspects in the production of vectorsand genetically modified somatic cells.pdf (64KB)
4.8 Impurities in new active substances.pdf (112KB)
4.9 Impurities in new medicinal products.pdf (32KB)
4.10 Production and quality control of medicinal products derived by recombinant DNA technology.pdf (71KB)
4.11 Production and quality control of cytokine products derived by biotechnological processes.pdf (41KB)
4.12 Production and quality control of MABs.pdf (41,5KB)
4.13 Quality of biotechnological products production of RDNA derived protein products.pdf (13KB)