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FDA: Q4B - Annex 6 Uniformity of Dosage Units General Chapte

25.09.2014
This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their ...

GMP: Complaints and Recalls: new EU-GMP Chapter 8 published

25.09.2014
The European Commission has published the final Chapter 8 of the EU Guidelines for GMP (Complaints, Quality Defects and Product Recalls). The chapter has been revised completely. ...

EMA: New legislation for veterinary medicines

11.09.2014
European Medicines Agency welcomes European Commission proposal to increase availability of medicines across Europe. New rules have been proposed by the European Commission to improve the health ...

EMA: Note for guidance on the format and content of the annual report on the state of development of an orphan medicinal product

11.09.2014
Article 5 (10) of Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products requires sponsors to submit annual reports on the state ...

GMP: Current FDA\'s Warning Letters on IT Topics - Part 2: Finished Medicinal Products and APIs

11.09.2014
In a first stage of escalation - when serious GMP deviations are identified during inspections, or in case of insufficient corrective measures - the FDA issues a Warning Letter to the companies ...

GMP: Still a GMP problem? Or already a criminal act? Do we need more stringent measures and enforcement in certain situations?

11.09.2014
When GMP issues are discussed, different interpretations are possible. Sometimes, the implementation of GMP regulations and expectations can be a challenge. However, everyone involved should do ...

EMA: Regulatory information - European Medicines Agency updates guidance on European Union periodic-safety-update-report single assessment for nationally authorised medicines

04.09.2014
The European Medicines Agency (EMA) has updated its procedural guidance to ensure that marketing-authorisation holders are prepared for the submission of periodic safety update reports (PSURs) for ...

EMA: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

04.09.2014
This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on ...

RAPS: As FDA Tries to Regulate Lab-Developed Tests, Congress Signals Potential Opposition

04.09.2014
On 1 August 2014, FDA released a new draft guidance document, Framework for Regulatory Oversight of LDTs, that proposes regulating LDTs more or less like IVDs. Under FDA\'s proposed regulatory ...

GMP: Questions and Answers on the Topic \"Pharmaceutical Water\"

04.09.2014
During courses and conferences participants quite frequently raise questions on pharmaceutical water preparation and distribution. Therefore following you will find some of these questions and ...