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EMEA: Opinions and decisions on PIP applications

09.07.2009
EMEA decisions on paediatric investigation plans (PIPs), including deferrals and waivers, and on modification of an agreed PIP. ...

ICH: Q4B Annex 5: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter

06.07.2009
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the ...

ICH: Q4B Annex 8: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Sterility General Chapter

06.07.2009
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the ...

FDA: Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs

03.07.2009
FDA developed question and answer resource on Current Good Manufacturing Practices. ...

Polish Ministry of Health: Regulation project on the Good Manufacturing Practices

03.07.2009
Polish Ministry of Health: Regulation project on the Good Manufacturing Practices ...

EMEA: Overview of status of HMPC assessment work - priority list

30.06.2009
Overview of status of HMPC assessment work - priority list ...

EMEA: Qualification of novel methodologies for drug development: Guidance to applicants

30.06.2009
As the scientific knowledge and the intended use of a new method may change in line with the generation of additional data the EMEA qualification process may encompass an ongoing interaction ...

EMEA: Dossier requirements

30.06.2009
It is presented dossier requirements for Post-authorisation submissions in the centralised procedure ...

MHRA: MLX 357 - Outcome of consultation on measures to strengthen the medicines’ supply chain and reduce risk from counterfeit medicines

30.06.2009
This consultation sought your views on a number of proposals to improve the operation of the medicines’ supply chain in the UK. It also sought views on European Commission proposals to amend ...

FDA: Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs

30.06.2009
As part of the cGMP initiative announced in August of 2002, and to help FDA be more transparent with cGMP policy, FDA has developed this question and answer resource on Current Good Manufacturing ...