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The regulations in the GMP area, and thus also the framework conditions for your company, are constantly changing.
Stay on the safe side with us!

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

08.11.2019

The Swiss Agency for Therapeutic Products (Swissmedic) is working on adapting the requirements for combination products to the new EU Medical Devices Regulation (MDR). A notification was published on the Swissmedic website on 5 November 2019.

08.11.2019

On 4 November 2019, the ICH has published the survey results on the level of implementation and adherence to ICH Guidelines within its Regulatory Member and Observer countries. The results have been compiled in a 26 page report. Especially interesting is the resulting tabular overview of the data including a search function:

31.10.2019

On its website, the European Commission has officially announced that the launch of the European Database on Medical Devices, EUDAMED, has been postponed:

29.10.2019

On 22 October 2019, the European Medicines Agency (EMA) released an revised and updated Q&A on the implementation of the EU Medical Devices Regulation (MDR) and EU In Vitro Diagnostic Regulation (IVDR).

11.10.2019

According to the ICH, the PDE value for ethylene glycol was reinstated to its previous PDE value of 6,2 mg/day and a concentration limit of 620 ppm. This value was changed in October 2018 with the ICH Q3C(R7) version  to a PDE of 3.1 mg/day and a concentration limit of 310 ppm. The process was then preceded by an error correction procedure (we reported).

11.10.2019

On 10 October 2019, the European Commission announced the first Notified Body designated under the EU Vitro Diagnostics Regulation (IVDR).

04.10.2019

The updates on this document are overturning: On 25 September 2019, the European Commission published Version 16 of the document on safety features for medicinal products for human use. 

25.09.2019

On 19 September, the notified body TÜV SÜD announced the certification of the first Class III medical device in accordance with the new EU Medical Devices Regulation (MDR).

20.09.2019

On 3 September 2019, the UK notfied body BSI announced the Novartis Concept1 inhaler as first medical device certified under the new EU Medical Devices Regulation (MDR).

16.09.2019

The United States FDA works on the harmonisation of the Quality System Regulation, 21 CFR 820 with ISO 13485, the international standard for quality management of medical devices (we reported), saying that

06.09.2019

In summer 2018, production-related contamination of the antihypertensive valsartan with the nitrosamines NDMA and NDEA caused a stir in the pharmaceutical world (we reported). A risk assessment conducted by the European Medicines Agency (EMA) followed this. The results can be found in the detailed EMA report from February 2019.

29.08.2019

A Q&A published by the European Medicines Agency (EMA) on 28 August 2019 clarifies when exemptions from batch re-testing of imported advanced therapy medicinal products (ATMPs) are permitted.

23.08.2019

On August 20, 2019, the US FDA published a warning letter to Ningbo Huize Commodity Co., a Chinese manufacturer of OTC drugs. The case concerns serious violations of good manufacturing practice and, in this context, the serious manipulation of data. In addition to this the FDA has gone public with detailed information.

21.08.2019

As announced by the European Commission on 20 August 2019, the IMQ Istituto located in Milan, Italy, has been notified as the fourth Notified Body under the new European MDR to come in 2020. This is still too little, according to the opinion within the medical device industry.

15.08.2019

In addition to BSI UK and TÜV Süd, the German DEKRA Certification GmbH is now recognised as a third Notified Body for the EU Regulation 2017/745 (MDR).

08.08.2019

According to RAPS, a US-statement to the Committee for Technical Barriers to Trade of the World Trade Organization (WTO) from 24 July 2019, raises concerns regarding the implementation of the new European Medical Devices Regulation (MDR) and the Regulation on In Vitro Diagnostics (IVDR). The MDR is already due to enter into force on 26 May 2020, the IVDR in 2022.

02.08.2019

From today’s perspective, the UK will be a third country as of 1 November 2019. As a result, all  batch  testing  facilities will have to be fully transferred to the EU27/EEA by  1  January  2020.  The European Commission has now published a reminder announcement regarding the requirement of batch release sites to be established in the EU. This applies also to MAHs which were granted an exemption to continue relying on quality control testing performed in the UK earlier this year (we reported).

29.07.2019

The TGA (Australian Therapeutic Goods Administration) has expressed concern about a looming shortage of Notified Bodies under the new Medical Device and In Vitro Diagnostics Regulations (MDR/IVDR) in Europe. Not without reason, though.

16.07.2019

As the EMA announced on 12 July 2019, Slovakia is the last EU member state to be recognized by the USA under the Mutual Recognition Agreement (MRA).

12.07.2019

In England, imported medicines have appeared which have apparently been removed or "stolen" from the legal supply chain in order to be reintroduced later into regular sales. With this, both correct transport and appropriate storage conditions are no longer guaranteed.

05.07.2019

On 1 July 2019, the Medical Device Coordination Group (MDCG) published two guidance documents on the Medical Device Regulation (MDR) and the In-Vitro Diagnostics Regulation (IVDR).

28.06.2019

On 26 June 2019, the US FDA granted Germany the ability to carry out GMP inspections at a level equivalent to that of the USA. With this, the MRA between the US and the EU has almost reached its goal: By 15 July 2019, the recognition of all 28 EU Member States should be completed.

28.06.2019

The European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT), together with the GMDP Inspectors Working Group and the Blood Products Working Party, released a Q&A document on how companies should handle OOS batches of authorized cell or tissue-based advanced therapy medicinal products (ATMPs). For manufacturers, importers and Marketing Authorisation Holders of ATMPs this 2-page document will be of good value.

25.06.2019

Across the EU, an increasing number of discussions are highlighting concern about the challenges facing each stakeholder in the sector (manufacturers, notified bodies, authorised representatives, distributors, competent authorities, European Commission) in implementing the new MDR/IVDR Regulations on time and effectively.

21.06.2019

The ICH (International Council for Harmonisation) met from 1 to 6 June 2019 in Amsterdam, Netherlands. 

18.06.2019

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

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

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

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 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

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

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

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

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

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

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

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 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

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

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

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

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

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

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

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

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

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

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.

01.02.2019

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:

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