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The regulations in the GMP area, and thus also the framework conditions for your company, are constantly changing.
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Every week we monitor more than 50 websites, including the most important authorities worldwide, international organizations and industry associations.
In addition, we gather information on international news portals on current pharmaceutical topics.

Any relevant information about new and revised regulations or new trends are then published on our news portal "News about GMP/cGMP".

Our news as rss feed:

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News about GMP/cGMP

18.06.2019

BfArM reports further Xarelto® counterfeits

Once again, two counterfeit batches of the drug Xarelto® 20 mg from the original manufacturer Bayer AG in Polish-Slovak packaging were discovered at a parallel distributor in Great Britain. Xarelto®, with the active ingredient Rivaroxaban, is used to prevent strokes and systemic embolisms as well as to treat pulmonary embolisms and venous thromboses.

14.06.2019

EU/US MRA on inspections: Luxembourg and the Netherlands accepted

On 10 June 2019, the FDA has confirmed the capability, capacity and procedures in place of Luxembourg and the Netherlands to carry out GMP inspections at a level equivalent to the US. This concludes the FDA's assessment of a total of 26 EU member states, whose inspection results will be trusted in the future. This process is to be completed for all EU states by 15 July 2019.

07.06.2019

EC: 20 Questions & Answers about Notified Bodies

On 6 June 2019, the European Commission published a Q&A document to clarify new obligations under the medical device and in vitro diagnostic regulations (MDR/IVDR) regarding notified bodies (NBs).

The 8-page document has been endorsed by the Medical Device Coordination Group (MDCG). The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.

It answers four sets of questions on a range of MDR/IVDR requirements relating to NBs. The clarifications cover organizational and general requirements, as well as resources requirements and process requirements.

03.06.2019

WHO: Technical Report Series 1019, 2019 published

The WHO Expert Committee on Specifications for Pharmaceutical Preparations meets annually and their reports (Technical Report Series) include all adopted guidelines in the form of Annexes.

With the publication of the 53nd Technical Report Series No. 1019 of the WHO, several new and revised Guidelines were adopted and recommended for use.

27.05.2019

TÜV SÜD designated as second Notified Body for MDR

TÜV SÜD Product Service was designated by the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) as the second Notified Body for the EU Medical Devices Regulation (MDR).

23.05.2019

PIC/S Meeting: What’s new for GMP?

In April 2019, the PIC/S Committee and the PIC/S Executive Bureau met in Geneva, Switzerland. The meeting was attended by 45 out of 52 PIC/S Participating Authorities as well as by a number of Applicants, Pre-Applicants, Associated Partners and Guests. Here are the topics addressed in the area of GMP:

17.05.2019

EC confirms: Korean APIs in line with EU standards

On 14 May 2019, the European Commission confirmed that the quality of APIs produced in the Republic of Korea is in line with EU standards. APIs manufactured in third countries like the Republic of Korea, and intended for the EU market, have to be produced in an EU equivalent regulatory system. This includes the rules for GMP.

14.05.2019

EMA Publishes Sterile Manufacturing Guidance

In March 2019, the European Medicines Agency (EMA) published the 25-page final version of the guideline "Sterilisation of the Medicinal Products, Active Substance, Excipient and Primary Container". The document will enter into force on 1 October 2019.

07.05.2019

Q&A on Safety Features for Medicinal Products in Version 14

The European Commission published Version 14 of the Q&A document on Safety Features for Medicinal Products for Human Use at the beginning of this month. The document complements the Counterfeiting Directive 2011/62/EU and the Delegated Regulation (EU) 2016/161.

03.05.2019

EU/US MRA on Inspections: Bulgaria and Cyprus accepted

On 29 April 2019, the FDA has confirmed the capability, capacity and procedures in place of Bulgaria and Cyprus to carry out GMP inspections at a level equivalent to the US. This concludes the FDA's assessment of a total of 24 EU member states, whose inspection results will be trusted in the future. This process is to be completed for all EU states by 15 July 2019.

26.04.2019

Switzerland: Legal uncertainty for medical device manufacturers

In terms of the InstA (Institutional Agreement) between Switzerland and the EU, there is legal uncertainty. This directly impacts the entire medical technology industry in Switzerland, as it does not ensure an update of the MRA (Mutual Recognition Agreement) Switzerland/EU. Will the third country requirements of the MDR perhaps soon apply to Switzerland? And what has to be done to be prepared?

17.04.2019

EU GMP Annex 1: When will the final version be released?

It has been and continues to be speculated when the final version of Annex 1 on the sterile manufacture of medicinal products will finally be published. At the beginning of this month, the issue was also discussed at the ISPE Annual Conference in Dublin. Dr. Sabine Paris from the editorial office of the GMP-Verlag was on site and brought these news with her:

29.03.2019

EMA: Brexit-Q&A to the prevention of medicine shortages

EMA has published a 3-page questions-and-answers document (Q&A) on the work that the EU authorities are doing to prevent medicine shortages due to the United Kingdom’s withdrawal from the EU.

29.03.2019

ICH: New Inhalation-PDE for Cadmium in Q3D-Guideline

On 22 March 2019, ICH published the final revision of the Guideline for Elemental Impurities Q3D (R1). The reason for the revision is an adjustment of the PDE value for cadmium by inhalation.

15.03.2019

FDA: New Acting Commissioner Named

One week after the surprising resignation of FDA Commissioner Scott Gottlieb, Norman E. Sharpless, Director of the National Cancer Institute (NCI), was appointed Deputy Commissioner of the FDA, according to media reports.

15.03.2019

MHRA: Six more documents on No-Deal Brexit

Brexit - and no end in sight. In preparation for a "No-Deal-Scenario", the British Medicines and Health Products Regulatory Authority (MHRA) published six new guidelines on a "No-Deal-Brexit" - five on the import and export of medicines and active ingredients and one on paediatric studies.

08.03.2019

FDA: CDER List for Planned Guidance Documents in 2019

The U.S. Food and Drug Administration (FDA) published the yearly list of new and revised draft guidances, CDER is planning to release in 2019. A total of 93 planned guidance documents have been set out which are categorised in 15 different themes.

08.03.2019

Brexit: News to Exemption for Batch Testing

As already reported, Marketing Authorisation Holders (MAHs) who are unable to transfer their batch testing site from the UK to the EU27 by 29 March 2019 may be permitted, for a limited period of time, to rely on quality control testing performed in the UK under certain conditions.This exempting provision has now been officially included in the EMA practical guidance as the 31st question:

Can I request a delay for transfer of batch control testing to the EU/EEA?

Furthermore, the EMA provides a 3-page template to be used for submitting such requests to the EMA.

01.03.2019

EMA publishes Q&A to MDR-/IVDR Compliance

On 27 February 2019, the EMA published a question and answer document for the practical implementation of Regulation (EU) 2017/745 for medical devices (MDR) and Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDR).

01.03.2019

Brexit and EU: Exemption for Batch Testing

With not even one month left until Brexit, the European Commission has sent a letter to the Director of the EMA (European Medicines Agency) and the EU27 Heads of Medicines Agencies to inform about an exemption to certain batch testing requirements for pharmaceutical manufacturers that perform their batch testing in the UK.

22.02.2019

Swissmedic uses EU’s EudraGMDP database

As reported by the European Medicines Agency EMA, the Swiss Agency Swissmedic, has started in 2019 to enter information on GMP compliance as well as on manufacturing authorisations related to Swiss manufacturers into the European Union’s EudraGMDP database. This applies for all new or renewed manufacturing authorisations and the related GMP-certificates issued using new templates (similar to those of EMA). This will allow replacing the current practice of issuing paper documents, i.e. GMP and should lead to easier information-sharing and efficiency gains for all stakeholders.

22.02.2019

MHRA: Guidances on No-Deal-Brexit

The British MHRA (Medicines and Healthcare Products Regulatory Agency) has launched a new website  containing all guidances and documents released for a no-Brexit-deal.

15.02.2019

EU/US MRA on Inspections: Poland and Slovenia accepted

On 7 February 2019, the FDA has confirmed the capability, capacity and procedures in place of Poland and Slovenia to carry out GMP inspections at a level equivalent to the US. This concludes the FDA's assessment of a total of 22 EU member states, whose inspection results will be trusted in the future. This process is to be completed for all EU states by 15 July 2019. According to the EMA the plans for the agreement to come into operation in all EU Member States by 15 July 2019 are well on track. As Germany is still not officially recognised, the US FDA will continue to carry out its inspections there.

08.02.2019

EMA/EC: Brexit Guidance Documents Updated

The European Medicines Agency and the European Commission have updated the following three documents related to Brexit that are intended to complement each other:

01.02.2019

US-EU Trade Agreement: News for the GMP sector

The Executive Working Group, EWG has published an interim report on the current status of its work. The focus is on the development of short- and medium-term practicable solutions in regulatory matters. In the area of pharmaceuticals and medical devices, the following approaches are being pursued or further pursued:

01.02.2019

EMA: Brexit Preparedness Plan in Phase 4

The relocation of the European Medicines Agency EMA to the Spark building in Amsterdam is proceeding according to plan. The move from London to Amsterdam should be completed by 1 March 2019. From 4 March, the EMA will then officially operate under a new address and the EMA staff will move into the new domicile in the week from 11 to 15 March.

25.01.2019

PIC/S Work Plan 2019

At the beginning of the year, PIC/S published its annual work plan for 2019. In addition to organisational matters, a new group of experts on veterinary medicines will be set up and the training of inspectors will be further expanded. In the area of harmonisation, PIC/S is actively involved in the revision of the EU GMP guidelines.

25.01.2019

Q&A to Safety Features in new Version 13

In January 2019, the European Commission published a new version 13 of the Questions and Answers document on Safety Features for Medicinal Products for Human Use. Nine new questions were added and one question was revised.

11.01.2019

ICH-Meeting in Charlotte, USA

The International Council for Harmonisation (ICH) met in Charlotte, USA, from 10 to 15 November 2018. The steadily increasing number of members (16) and observers (28) is an indication of the continuous development of the ICH into a global initiative. During the General Assembly, the Iranian authority NRA was welcomed as a new regulatory member.

 

18.12.2018

ICH Q2/Q14: Final Concept Paper for Analytical Procedure Development

The International Council for Harmonisation (ICH) has published the final concept paper for ICH Q14 (Analytical Procedure Development) on its website. In the course of the preparation of this new guideline, ICH Q2 (Validation of Analytical Procedures) will also be revised. It will be adapted to the state of the art to include modern analytical methods in the future. Both guidelines are intended to supplement the existing documents ICH Q8 - ICH Q12.

 

18.12.2018

ICH: Final Concept Paper to ICH Q13 „Continuous Manufacturing“

The Management Committee of the ICH has endorsed the final concept paper and business plan on the new quality guideline ICH Q13 on continuous manufacturing for drug substances and drug products. Both documents are published on the ICH website.

 

14.12.2018

FDA Finalises Guidance on Data Integrity

On 13 December 2018, the US FDA has announced the availability of the final guidance for industry “Data Integrity and Compliance with Drug CGMP: Questions and Answers.” The guidance updates a draft version released in 2016. It has been revised to include additional information on the agency’s current thinking on best practices and covers the design, operation and monitoring of systems and controls to maintain data integrity.

07.12.2018

European Council Adopts Animals Medicines Package

As stated in a European Council press release on 26 November, the Council of the EU adopted the "Veterinary Medicinal Products Package" with two new Regulations in the following areas:

  • veterinary medicinal products
  • the manufacture, placing on the market and use of medicated feed

and changes to the existing rules laying down procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

07.12.2018

PIC/S: Revised Draft Guidance for Data Integrity

On 30 November 2018, the PIC/S has published Draft No 3 of the “Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments” (PI 041-1) for a focused stakeholder consultation.

 

30.11.2018

New Version of Q&A to Safety Features for Medicinal Products

The 28-page document setting out frequently asked Q&As regarding the implementation of the rules on the safety features for medicinal products for human use has been revised. As of November 2018, it is available in Version 12.

The changes compared to the superseded version regard questions 1.20 and 2.21:

30.11.2018

MRA EU-US: Five Additional European Countries Named

On 16/28 November 2018, the US Food and Drug Administration (FDA) confirmed the capability of the following five additional EU Member States to carry out GMP inspections at a level equivalent to the United States:

23.11.2018

EMA reports impurities in Valsartan from Mylan

On 19 November 2018, the EMA informed on their website that Valsartan from the Indian manufacturer Mylan Labortories is currently not allowed to be used for the production of medicinal products containing Valsartan for the EU. The CEP (Certificate of Suitability) of Mylan has been suspended by EDQM (European Directorate for the Quality of Medicines and Healthcare) because N-nitrodiethylamine (NDEA) has been found in some batches of valsartan.

23.11.2018

EU and Health Canada plan to include GMP inspections on APIs in MRA

The Comprehensive Economic and Trade Agreement (CETA) between the EU and Canada also includes the CETA GMP Protocol. In continuation of the MRA of 2003 between the EC and Health Canada this protocol also confirmed the  continued  mutual  recognition  of  GMP  inspections  and  batch  certification  between  EU  and  Canada  for  medicinal  products  for  human  use  and  veterinary medicines.

16.11.2018

EMA: Draft Guideline on the Quality of Water for Pharmaceutical Use

On 15 November 2018, the EMA has published a draft of the “Guideline on the Quality of Water for Pharmaceutical Use” for public consultation until 15 May 2019.

This 10-page document, once final, will replace the current “Note for guidance on quality of water for pharmaceutical use” from 2002 and the “CPMP Position Statement on the Quality of Water used in the production of vaccines for parenteral use".

09.11.2018

EMA: Brexit Preparedness Plan Phase 3

The parallel preparing of the UK’s exit from the EU, the physical move to Amsterdam and operating “business as usual” as long as possible is the declared aim of the EMA. As of October 2018, EMA has launched Phase 3 of the “Brexit Prepardness Plan”, which results in additional temporary suspensions and scaling back of activities.

09.11.2018

Australia and Canada expand their MRA

As of November 1, 2018 the Therapeutic Goods Administration (TGA) of Australia and Health Canada expanded their mutual recognition agreement (MRA) to cover active pharmaceutical ingredients (APIs).

02.11.2018

PIC/S-Meeting 2018 in Chicago

The PIC/S Committee met on 24-25 September 2018, in Chicago. The meeting was attended by 38 Participating Authorities as well as by a number of Applicants, Pre-Applicants and Associated Partner Organisations. The event was hosted by the US FDA which symbolised the effort to strengthen inspectional approaches and assessments worldwide and to further share and discuss respective regulatory decisions and information. The keyword “harmonisation” and the impact of PIC/S on this matter had been especially highlighted by the FDA.

26.10.2018

PANGEA XI: 500 Tonnes of Illegal Online Pharmaceuticals Seized

This year’s Operation PANGEA – an international effort to disrupt the online sale of fake and unlicensed health products around the world – took place from October 9 to 16, 2018. Starting with just eight countries in 2008, the operation has grown to 116 countries that participated this year.

 

26.10.2018

ICH Q3C(R7) Published with Correction of PDE for Ethylenglycol

As announced on the ICH website on October 25, the ICH Q3C(R7) Guideline along with Q3C Support Documents 1, 2, and 3 have now been published. The new R7-version of ICH Q3C is the result of an error correction of the Permitted Daily Exposure (PDE) for ethylenglycol as per the correct value calculated in Pharmeuropa, Vol. 9, No. 1, Supplement, April 1997 S36.

19.10.2018

CDSCO: Draft of Indian Schedule M published

According to pharmabiz.com, the Indian regulatory authority CDSCO has published a draft version of the revised Schedule M. However, the document is currently only available in Indian language.

12.10.2018

MHRA asks for comments on “No-deal” Brexit

On October 4, the British MHRA (Medicines and Healthcare products Regulatory Agency) has launched a public consultation seeking views on how the agency’s legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no implementation period. This consultation covers no-deal proposals on medicines, clinical trials and medical devices.

12.10.2018

FDA introduces cGMP Declarations

On September 17, the US FDA announced a new online application, cGMP declarations. FDA's CDER will send ‘cGMP declarations’ to regulatory authorities in other countries where US firms want to market drug products.

05.10.2018

CDRH publishes proposed Medical Device Guidance Development 2019

On 3 October 2018, the US FDA’s Center for Devices and Radiological Health (CDRH) has published three lists of guidance documents that may be published in 2019:

 

28.09.2018

CDRH works on blending ISO 13485 with 21 CFR 820

We have already reported about the intention of the US FDA/CDRH to changing its quality system requirements for medical device manufacturers and utilise the International Organisation for Standardization (ISO) updated quality management standard, 13485:2016. Obviously the intention has already been put into action.

21.09.2018

EU/US MRA on Inspections: Portugal accepted and Q&A updated

On 14 September 2018 the FDA has confirmed the capability, capacity and procedures in place of Portugal to carry out GMP inspections at a level equivalent to the US. There are now a total of 15 European Member States whose inspection results the FDA relies on to replace their own inspections.

 

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