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  • Novidades da 19ª semana (06 a 12 Maio) 0

ECA - EUROPEAN COMPLIANCE ACADEMY

GMP Deficiencies in Packaging

A US-American pharmaceutical manufacturer has recently received a Warning Letter from the FDA due to deficiencies in packaging and quality assurance.

 

CSA (Computer Software Assurance) - Position Paper from GAMP Francophone

About 2.5 years ago, the FDA announced a Guidance for Industry on Computer Software Assurance (CSA). However, this guidance has not yet been published. Currently, GAMP Francophone has published a first position paper on this issue.

 

Q&As Cleaning Validation - Part I

In March the ECA offered the first Cleaning Validation Online Training Course - with many questions for the speaker. The ECA would like to share a selection of these Q&As on Cleaning Validation with the community.

 

Reprocessing of Medical Devices - Implementing Regulation for Single-Use Devices

The reprocessing of single-use devices in the medical device sector is left to the EU Member States. However, only the national law of the respective member states must allow this. Now, an implementing regulation is available which describes common specifications for reprocessing single-use devices.

 

 

EDQM

PDG 2020 autumn meeting held by videoconference

The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia, held its annual autumn meeting via videoconference on 22-23 September 2020, with WHO attending as observer. Due to the COVID-19 pandemic, the face-to-face meeting originally scheduled was reorganised as a videoconference devoted entirely to strategy and policy topics.

 

 

EMA – EUROPEAN MEDICINES AGENCY

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2020

EU regulators request nitrosamine testing of metformin medicines

EMA and EU national competent authorities will be contacting all marketing authorisation holders of metformin-containing medicines, used for the treatment of diabetes, to request they implement testing of the medicines for the presence of nitrosamines before they are released onto the market.

Minutes: Minutes of the CVMP meeting of 8-9 September 2020 meeting (new)

 

Template form: Marketing authorisation application (MAA) - pre-submission meeting request form (human) (updated)

 

Human medicines highlights - October 2020 (new)

 

Applications for new human medicines under evaluation by the CHMP: October 2020 (new)

 

Agenda - CHMP agenda of the 12-15 October 2020 meeting (new)

 

Regulatory and procedural guideline:

 

Dates of 2021 Scientific Advice Working Party (SAWP) meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests

 

 

FDA

Coronavirus (COVID-19) Update: Daily Roundup October 15, 2020

 

 

GDP Association

ECA GDP Association represented at 5th Annual International GDP Conference in Serbia

 The "5th Annual International Conference - Good Distribution Practice" organised by the Quality Association of Serbia was held in Belgrade, Serbia on 26th September 2020. The Director of Regulatory Affairs and Communications, Prabjeet Dulai, was invited by the Program Committee to represent the ECA GDP Association and give the introductory session, aptly titled "The Power of Building Relationships - role of the European GDP Association."

 

 

HMA - CMDH

UPDATE - CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines

Marketing authorisation holders should review their manufacturing processes for all products containing chemically synthesised or biological active substances to identify and, if necessary, mitigate the risk of presence of nitrosamine impurities.

MSs Recommendations on Extension Applications in Mutual Recognition and Decentralised Procedures [Track version]

Timetables 2021 for requests to CMDh for a recommendation on classification of an unforeseen variation - Article 5

 

29 September 2020

 

 

ICH

The ICH Q3D(R2) draft Guideline available now on the ICH website

The extracts with the amendments to the ICH Q3D(R2) draft Guideline for Elemental Impurities, which show the revisions to Appendix 2 and 3 further to corrections of the Permitted Daily Exposure (PDEs) for Gold, Silver and Nickel as well as a new Appendix 5 on Limits for Elemental Impurities by Cutaneous and Transcutaneous Route, reached Step 2b of the ICH Process in September 2020 and now enters the consultation period.

 

 

INFARMED

Decreto-Lei n.º 87-A/2020 - Diário da República n.º 201/2020, 1º Suplemento, Série I de 2020-10-15

Altera as medidas excecionais e temporárias relativas à pandemia da doença COVID-19

 

 

EFPIA – European Federation of Pharmaceutical Industries and Associations

Biopharmaceutical industry support EU regulators exceptional transparency measures and call other regulatory authorities to follow suit to help ensure confidence in the science and the decision-making

IFPMA & EFPIA support European Medicines Agency’s (EMA) initiative to implement exceptional transparency measures that are targeting regulatory activities for the assessment and approval of medicines and vaccines for COVID-19.

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