| 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) |
