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News about GMP/cGMP

EMA: Annual Report 2020 published
18.06.2021

As every year, the EMA now publishes its report for 2020, in which it outlines achievements, decisions and objectives of the year.

FDA presents first global forum for generics
18.06.2021

In early June, the FDA unveiled the Generic Drug Cluster, the first forum for leading regulatory authorities to address the global development of generic drugs.

Operation PANGEA XIV: Worldwide week of action against criminal online trade in medicines
11.06.2021

Once a year, operation PANGEA takes place, a globally organized action by Interpol against the online distribution of illegally imported medicines. Within this week of action, participating countries check (and close) suspicious websites and seize counterfeit medicines. In addition, this action aims to create public awareness of the issue.

EMA: Updated guidance documents on parallel distribution
10.06.2021

The European Medicines Agency, EMA, has updated its regulatory and procedural guidance documents on parallel distribution as of 9 June 2021. 

CDRH (FDA): Medical devices from Steril Milano may not be sufficiently sterilized - import ban for the U.S.
07.06.2021

The two facilities of the Italian company Steril Milano S.r.L. in Monza and Reggiolo have closed their doors since March 2021. The company, which offers a sterilization service for medical devices, is facing serious allegations of manipulation. In the meantime, Steril Milano S.r.L's certificate has been withdrawn by the responsible accreditation body.

FDA: Two new guidelines on supply chain security
04.06.2021

The FDA has finalized two guidance documents to help ensure that prescription drugs are identified and traced properly while moving through the supply chain. The documents address how to comply with the DSCSA (Drug Supply Chain Security Act) requirements.

EC: EU MDR in force along with Q&A
28.05.2021

Finally the date has come: as of 26 May 2021 the EU rules on medical devices (EU MDR) entered into force. Following a one year postponement due to COVID-19, this regulation is considered a big step forward to improve the safety and quality of medical devices. There are, however, still plenty of uncertainties for their manufacturers, but there is also a saying that every journey begins with single steps.

Switzerland, EU-MDR und a missing MRA
28.05.2021

The new European medical device regulation came into force on 26 May 2021. Parallel, a complete revision of the Medical Devices Regulation MepV was carried out in Switzerland, under the responsibility of the Swiss BAG (Federal Office of Public Health). In context of the alignment of the MepV and the KlinV-Mep with the new EU regulations MDR and IVDR on medical devices, it was also necessary to update the existing MRA (Mutual Recognition Agreement) between Switzerland and the EU. This agreement ensures barrier-free market access and joint implementation. The MRA is, in turn, part of an "overall package" of an institutional framework agreement (Insta), which has not yet been conclusively agreed on. On the contrary: Switzerland has meanwhile broken off negotiations with the EU and described them as "having failed".

Swissmedic: First agreement on close cooperation with German Federal Office of Consumer Protection and Food Safety (BVL) for veterinary medicinal products
25.05.2021

On 18 May 2021, Swissmedic and the Federal Office of Consumer Protection and Food Safety (BVL) signed a first Memorandum of Understanding on cooperation in the area of veterinary medicinal products.

FDA: Update on remote inspections guidance and future roadmap
21.05.2021

On 17 May 2021 the USFDA has released a revised version of its Q&A guidance on remote inspections. The 14-page document was originally published in August 2020 (we reported). As the pandemic still restricts most onsite inspections the FDA further clarifies general questions that came up since then.

MHRA launches its own GMDP database
21.05.2021

The British MHRA has set up a standalone MHRA-GMDP database as a new service (alpha release). This step obviously separates the UK from the EudraGMDP where the competent EU authorities publish manufacturing and wholesale approvals, GMP certificates and non-compliance reports.

ICH: ICH Q3C(R8) Guideline for Residual Solvents contains new PDEs
07.05.2021

ICH published the revised version (Step 4) of the ICH Q3C(R8) Guideline on Impurities: Guideline for Residual Solvents on 22 April 2021.

PIC/S: Revision of the PIC/S GMP Guide PE 009-15
29.04.2021

As announced by PIC/S on 23 April, 2021, the PIC/S GMP Guide has been revised. The changes will take effect on 1 May 2021. 

FDA:New Guidance on remote interactive inspections
16.04.2021

On 14 April 2021 the US FDA has published a new guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency”. This in fact was long overdue.  It outlines 

  • how remote interactive evaluations will be requested by the FDA and 

  • how they will be conducted for the duration of the COVID-19 pandemic.

Swissmedic: Harmonization of requirements on nitrosamines with EU
16.04.2021

On 16 April 2021, Swissmedic announced that it is seeking harmonization with EU regulations regarding the handling of nitrosamine impurities.

FDA:  Patrizia Cavazzoni, M.D., to lead CDER
15.04.2021

On 12 April 2021, Dr Janet Woodcock, acting head of the US FDA, announced Dr Patrizia Cavazzoni's new role as director of CDER.

Export to UK: Exemption for Wholesalers
09.04.2021

The European Union has published the Delegated Regulation (EU) 2021/457 in its Official Journal on 17 March 2021. It amends the Delegated Regulation (VO) 2016/161 on safety features necessary for the packaging of medicinal products for human use. The amendment is to exempt the obligation for wholesalers to deactivate the unique identifier of medicinal products exported to the United Kingdom, being considered a third country now.

EMA: Q&A on the implementation of the Ireland/Northern Ireland Protocol
26.03.2021

EMA published Revision 3 of the Q&A on the Protocol on Ireland and Northern Ireland on 5 March 2021. The 11-page document contains 28 pairs of questions and answers. It is updated regularly and will be of interest to all GMP professionals who have business relationships with companies in Northern Ireland.

EMA: PDE for chlorobutanol as excipient reviewed
26.03.2021

The CMDh (EMA's Coordination Group for Mutual Recognition and Decentralized Procedures) has approached one of the EMA's Safety Working Parties (SWPs) with the following two questions regarding chlorobutanol:

  1. Can the Safety Working Party confirm that the levels of chlorobutanol commonly used in medicinal products are safe from a toxicological point of view?
  2. Is it possible to determine acceptable intake levels of chlorobutanol?

The EMA published the 15-page SWP response document to these questions on March 17, 2021.

MHRA to pick up on-site inspections by end of March
25.03.2021

The MHRA announces its return  to on-site risk based GxP inspections starting from 29 March 2021. However, it is planned to use a combined approach of both, remote and on-site inspections.

MDCG: Guidance on custom-made medical devices according to MDR
18.03.2021

The Medical Device Coordination Group (MDCG) published an eight-page Q&A document titled Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices (MDCG 2021-3) on 15 March 2021.

MHRA and EU: Medicinal products in Northern Ireland
12.03.2021

The European Commission published a Notice this January dealing with the legal framework for medicinal products marketed in Northern Ireland. On 9 March 2021, the UK MHRA, for its part, followed up and also addressed the issue. 

Swissmedic: Data on imports of illegal medicinal products via the internet
12.03.2021

On 4 March 2021, Swissmedic announced the numbers on medicinal products illegally imported into Switzerland. In 2020, 6733 illegal imports were recorded. Compared to the previous year, the number has decreased only slightly.  Among the countries of origin, Singapore has replaced India, which has long been in the lead. It was followed by Western European countries such as the UK and Germany in particular.

Singapore is increasingly being used as a hub by suppliers of illegal medicinal products.

WHO/IAEA: Draft Guidance on GMP for Investigational Radiopharmaceutical Products
10.03.2021

WHO published a 31-page draft guideline, "GMP for investigational radiopharmaceutical products", in March 2021. It offers recommendations for minimum standards in the manufacture of new radiopharmaceuticals for Phase I-III clinical trials that do not have a marketing authorization (MAA).

EDQM: Revision of Certification of Suitability for a Sartan monograph
05.03.2021

As reported earlier, the European Pharmacopoeia Commission implemented five new sartan monographs in a rapid procedure at the end of February. They are scheduled to become effective already on 1 April 2021. For holders of a Certification of Suitability (CEP), this may, but does not necessarily, mean adjusting their control strategies for nitrosamine impurities. EDQM has now published supplemental information on this topic:

EDQM: Five Pharmacopoeia monographs on Nitrosamine contamination in Sartans revised and implemented immediately
26.02.2021

On 23 February 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) announced that five monographs on sartans have been revised. They will be effective immediately as of 1 April 2021. 

EMA: Update on recommendations for handling nitrosamines
26.02.2021

On 22 February 2021, the European Medicines Agency (EMA) published a 14-page implementation plan dealing with the prevention of nitrosamine impurities. It is based on the results of the CHMP's scientific review of the subject.   

EUDAMED: Management of legacy devices
25.02.2021

On 15 February 2021, the European Commission published a 13-page document on the management of legacy devices. It clarifies questions on how these will be identified in EUDAMED or how the different Unique Device Identifiers (UDI) will be generated or assigned.  

FDA: Revision of Nitrosamine Guidance and extension of timeframe for risk assessments
25.02.2021

On 24 February 2021, the U.S. Food and Drug Administration announced a revision to its September 3, 2020, Guidance for Industry, Control of Nitrosamine Impurities in Human Drugs. The revision extends the recommended timeframe for manufacturers to assess the risk of nitrosamines in active pharmaceutical ingredients (APIs) and drug products from 6 to 7 months.

Swissmedic: Permanent participation in "Orbis"
25.02.2021

On 17 February 2021, Swissmedic announced that it will now permanently support the "Orbis" project. Orbis enables manufacturers to submit their marketing authorization applications submitted to the US FDA simultaneously to other international regulatory authorities, provided they participate in the project.

WHO: Draft Guideline on Medical Gases
19.02.2021

The WHO published a 29-page draft guideline on Good Manufacturing Practices for Medical Gases in February 2021. The reason given for this step is a sharp increase in the demand for medical gases, particularly oxygen used to provide respiratory care to covid patients.

EC: Italian Istituto Superiore di Sanità becomes 19. Notified Body
19.02.2021

As announced by the European Commission on 18 February 2021, the Italian Istituto Superiore di Sanità (ISS) has been designated as the 19. Notified Body under the EU Medical Devices Regulation (MDR) 2017/745.

EMA: GMP requirements for herbal extracts during early manufacturing steps
15.02.2021

EMA published the document "GMP requirements applicable to the early manufacturing steps for comminuted plants and herbal extracts used as active substances" in February 2021.

EMA: Manufacturers to test rifampicin for nitrosamine impurities
15.02.2021

Following the detection of 1-nitroso-4-methyl-piperazine (MeNP) impurities in some batches of rifampicin in February 2021, the EMA is requesting manufacturers to test the drug for the presence of MeNP. 

EMA: Pilot Project "OPEN" to Collaborate with Non-EU Authorities During COVID-19
05.02.2021

The European Medicines Agency (EMA) has launched an initiative to collaborate with non-EU authorities and WHO to drive the evaluation processes for COVID-19 vaccines and therapeutics.

PIC/S: Jordan applies for membership
05.02.2021

As announced on 26 January 2021, the Jordan Food & Drug Administration (JFDA) has submitted a complete application for membership to the PIC/S.

PMDA: Information on the procedure for remote inspections
28.01.2021

In January 2021, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) published the English translation of the document on remote inspections, Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products.

FDA: CDER agenda of all guidance documents planned for 2021
28.01.2021

This year's Center for Drug Evaluation and Research (CDER) list of guidance documents scheduled for publication includes 18 categories with a total of 105 documents.

PICS/S: Four Aide-Mémoires updated
22.01.2021

PIC/S has updated the following four Aide-Mémoires, which became effective on 1 January, 2021:

FDA: Janet Woodcock becomes acting commissioner
21.01.2021

Dr. Janet Woodcock has been appointed as acting commissioner of the FDA. The previous commissioner, Dr. Stephen M. Hahn, stepped down from his role at the start of President Biden's term of office.

Mutual recognition of inspections under the EU-UK Trade Agreement
19.01.2021

Questions about the EU-UK Trade and Cooperation Agreement, which will apply from January 1, 2021, were clarified by the European Commission in a 39-page Q&A on the EU-UK Trade and Cooperation Agreement on December 24, 2020. In total, it consists of 133 pairs of questions and answers.

PIC/S: Russia applies for membership
15.01.2021

The competent authorities of the Russian Federation submitted a complete membership application to PIC/S in Geneva on 13 January 2021. The rapporteur(s) will be appointed in written procedure or at the next meeting of the PIC/S Committee.

EC: Members appointed to MDR/IVDR expert panels
15.01.2021

In the second week of January, the European Commission (EC) published a list of members appointed to the MDR and IVDR expert panels. On 10 September 2019, the 12 expert panels were designated by the Commission Implementing Decision (EU) 2019/1396.

MHRA: UK and Canada – mutual recognition of GMP and batch testing certificates
14.01.2021

On 5 January 2021, the UK MHRA published a joint statement by the UK and Canada, which applies on an interim basis and is intended to avoid trade disruptions as a result of the Brexit. 

Brexit: The transition phase is over - MHRA publishes 48 documents
14.01.2021

The transition period until Brexit came into effect ended on 31 December 2020. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published another batch of documents for the processes that are now starting. They cover all aspects of the regulation of medicinal products and medical devices in the UK.

EC allows remote audits by notified bodies
14.01.2021

On 11 January 2021, the European Commission (EC) announced what needs to be considered when Notified Bodies conduct remote audits of medical device and in vitro diagnostic manufacturers due to the COVID-19 situation.

21.12.2020

Shortly before the end of the year, WHO published a 38-page draft with twelve chapters and two appedices on technology transfer in pharmaceutical manufacturing.

10.12.2020

In December 2020, the Medical Device Coordination Group (MDCG) of the European Commission published a six-page Q&A document on Notified Body audits of medical device manufacturers during the COVID 19 pandemic. 

10.12.2020

As announced by the UN Commission on 2 December 2020, cannabis was removed from Schedule IV of the 1961 Single Convention on Narcotic Drugs following WHO's recommendation.

04.12.2020

What should a crisis-proof drug supply in Europe resemble? In this regard, the European Commission presented a 25-page pharmaceutical strategy on November 25, 2020. It was awaited with great interest. One thing is for certain: the implementation of the strategy will not leave the EU pharmaceutical legislation unaffected.

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