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EMA: Regulatory information – Green light for reliance on Article 57 database for key pharmacovigilance information on medicines for human use in Europe

29.12.2015
As of 1 February 2016, for both centrally and nationally authorised medicines, companies will no longer be required to submit type IA variations in relation to the Qualified Person Responsible for ...

EMA: Regulatory information - Replacement of GCP non-compliant pivotal studies in centralised marketing-authorisation applications not accepted

29.12.2015
The European Medicines Agency (EMA) will not accept the replacement of a pivotal clinical study that has been found to be non-compliant with good clinical practice (GCP) by another study during ...

EMA: Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations II: biological medicinal products

29.12.2015
Product- or Population-Specific Considerations II: biological medicinal products. ...

RAPS: Proposed Rule Would Revise Regulations on Fixed-Combination Drugs

29.12.2015
The US Food and Drug Administration (FDA) is proposing a new rule that would apply its regulations on prescription fixed-combination drugs to a variety of nonprescription fixed-combination and ...

RAPS: FDA Warns Sun’s India Plant Over Sterility Concerns

29.12.2015
Serious aseptic and sterility violations, including water damage and leaks in parenteral manufacturing areas, were documented by the US Food and Drug Administration (FDA) in the latest warning ...

RAPS: FDA: Explosions at Chinese Chemical Warehouse Contaminated Drugs

29.12.2015
The US Food and Drug Administration (FDA) on Tuesday alerted compounders and drug manufacturers that shipments from Tianjin, China may be at risk of chemical contamination following two massive ...

GMP: Validation - Revision of Annex 15: How does the Industry see the Changes? - Results of an ECA Survey

08.10.2015
With the publication of a draft on the revision of Annex 15 at the beginning of February 2014, changes in the area of validation/qualification were to be expected. Even then, the ECA Academy ...

GMP: Genotoxic impurities: the new ICH M7 addendum to calculation of compound-specific acceptable intakes

08.10.2015
The final document of the ICH-Guideline M7 was published in June 2014. It describes the procedure for evaluating the genotoxic potential of impurities in medicinal products (see also our news ...

GMP: Has GMP Inspection Report of Slovenian GMP Inspectors caused FDA and Health Canada Import Alerts?

08.10.2015
In March 2015 the Slovenian GMP Inspectors have conducted a GMP Inspection at the company Polydrug Laboratories PYT. LTD. in Maharashtra, India. The Inspectors found 17 GMP deviations of which 5 ...

GMP: FDA Inspections at API Manufacturers - current Warning Letter Trends

08.10.2015
Taking a look at the Warning Letters the FDA issued after inspections of activesubstance manufacturers in the 2015 fiscal year, which ended on 30 September 2015, it is first of all striking that ...