GMP News - Regulatory Affairs

17.01.18

EMA revises Post-Authorization procedural Advice

The European Medicines Agency (EMA) recently revised its post-authorization procedural advice for users of the centralized procedure.

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20.12.17

Now online: Draft ICH Q12

The long awaited and highly discussed ICH Q12 draft Guideline is now available online on the ICH website. Read more about ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.

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06.12.17

Drug Safety: FDA´s new Draft Guidance Regarding REMS

The FDA recently published its new draft guidance on Risk Evaluation and Mitigation Strategy (REMS). Read more about Format and Content of a REMS Document.

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22.11.17

And the EMA goes to ... Amsterdam

When Britain leaves the EU, the European Medicines Agency (EMA) will have to move as well. The final decision where to was made by drawing the name of the new EMA location out of a hat. How could that happen?

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22.11.17

GVP Update 2017

There have been recent developments within EudraLex Volume 9 - Guidelines on good pharmacovigilance practices (GVP). Read more about the revisions of several GVP Modules and the published draft of Product- or Population-Specific Considerations IV: Paediatric population.

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16.11.17

EudraVigilance: EMA's new Signal Management Guide

In line with the go-live date of the new EudraVigilance database EMA now published the revised GVP module IX on signal management. The revised module IX will introduce major procedural changes for industry.

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16.11.17

FDA's new Guidances on the Approval of Generic Drugs

The FDA has recently published various guidelines on application procedures for generics. Read here, which special requirements have to be met for the authorisation application of generics for the US market.

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09.11.17

The ICH E11 Addendum on clinical investigation in children now enters into implementation

The ICH E11 Addendum reached Step 4 of the ICH Process and now enters into the implementation period. Read more about ICH E11 Clinical Investigation of Medicinal Products in the Pediatric Population.

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17.10.17

Similarity by Design: EMA Reflection Paper on statistical Methodology for comparative Assessment of QAs

The European Medicines Agency (EMA) recently released a draft Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development.

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20.09.17

FDA aligns Inspection and Regulatory Affairs Systems

The US Food & Drug Administration (FDA) plans to better coordinate regulatory affairs and field inspection activities to strengthen inspection and oversight of drug manufacturing worldwide.

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14.09.17

EMA´s Questions and Answers relating to Flexibility in Manufacturing Conditions

The EMA recently published a Questions and Answers document in relation to presentation of process information in the marketing authorization dossier and management of changes to an approved design space. Read more about the document on "Improving the understanding of NORs, PARs, DSp and normal variability of process parameters".

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14.09.17

EMA updates Website on Mutual Recognition Agreements

The European Medicines Agency, EMA, has updated its page on Mutual Recognition Agreements (MRA). Read more about the Questions and answers on impact of EU-US mutual recognition agreement on marketing authorization applications and relevant variations.

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13.09.17

API starting materials - New Q&A document for ICH Q11

The recently published ICH question/answer document on starting materials specifies the regulations of the guideline ICH Q11. Read more about what is important in terms of the selection of starting materials and their justification and what data needs to be supplied in the marketing authorisation dossier.

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12.09.17

QbD: New EMA Guideline on Manufacture of the finished Dosage Form

The EMA published its new Guideline on Manufacture of the finished dosage form. The new EU guidance will help applicants in preparing marketing authorization dossiers and in what to include in Module 3 of their common technical document.

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12.09.17

Safety by Design: EMA Reflection Paper on Development of Medicines for Use in the older Population

The EMA recently published a draft Reflection Paper on the pharmaceutical development of medicines for use in the older population.

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