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In addition, we gather information on international news portals on current pharmaceutical topics.

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News about GMP/cGMP

17.08.2018

The Compounding Expert Committee intends a revision of the General Chapter USP <797> Pharmaceutical Compounding – Sterile Compounding. The draft version has been published for public commentation until November 30, 2018.

10.08.2018

EMA reported, that it will lauch the next phase of its business continuity plan on 1 October 2018 at the latest. This will allow the Agency to safeguard core activities related to the evaluation and supervision of medicines, while it has to intensify its preparations for the physical move to Amsterdam in March 2019 and cope with significant staff loss.

03.08.2018

The MedTech Europe industry group calls on the European institutions to offer solutions to meet the deadlines for the new MDR and IVDR. Both regulations will apply from May 2020 and May 2022 respectively.

 

03.08.2018

The World Health Organization (WHO) has prepared a new questions and answers document to clarify earlier biosimilar guidelines. It will provide answers to questions asked by regulators over the last eight years.

20.07.2018

On 17 July 2018, the Members of the British Parliament voted 305-301 to continue a close collaboration with the EMA after Brexit. This amendment to the Brexit Trade Bill on ‘UK participation in the European medicines regulatory network’ means that British Government is now 'in charge' to negotiate an active and full participation in the EMA following the United Kingdom’s exit from the EU.

20.07.2018

The European Union and Japan have extended their Mutual Recognition Agreement (MRA) on 18 July 2018. The MRA now also includes sterile products, APIs and biologicals including vaccines.

13.07.2018

The European Medicines Agency EMA expresses “serious concerns” over the preparedness of some marketing authorisation holders for centrally authorised products with an important step in their regulatory processes in the United Kingdom (UK) regarding the necessary actions to smoothly transition once the UK will exit the EU in March 2019. This conclusion was drawn after evaluating the results of an industry survey which was initiated by the Agency in January 2018 (we reported).

05.07.2018

The ICH (International Council for Harmonisation) met in Kobe, Japan, from June 2 – 7, 2018. The corresponding press release provides insight on the topics discussed.

05.07.2018

The US FDA initiated two new programs on a voluntary basis to gather industry feedback regarding the use of quality metrics. Namely these are a

  • Quality Metrics Feedback Program and a
  • Quality Metrics Site Visit Program
05.07.2018

Highly Purified Water (HPW) wird aus dem europäischen Arzneibuch gestrichen, so berichtet die Europäische Arzneibuch-Kommission nach ihrer 160. Sitzung, die vom 20.-21. März 2018 in Straßburg stattfand. Die Monographie 1927 wird aufgrund der Redundanz von HPW und Wasser für Injektionszwecke (WFI) im April 2019 entfallen. Die revidierte Monographie für WFI (Wasser für Injektionszwecke, 0169) ist seit April 2017 in Kraft (wir berichteten).

 

29.06.2018

On 26 and 27 June 2018, the PDA Europe Annual Meeting took place in Berlin. Thomas Peither, Excecutive Editor and President of Maas & Peiter AG, participated in the conference and brought back interesting insights.

29.06.2018

The European Commission has now published the final version of Annex 2 "Manufacture of Biological active substances and Medicinal Products for Human Use". It is in operation since 26 June 2018.

29.06.2018

Almost two years after publishing a draft document of Annex 17: Real Time Release Testing the European Commission has now published the final version newly entitled Annex 17: Real Time Release Testing and Parametric Release. The eight-page document will come into operation on 26 December 2018 and will finally replace the preceding version of the year 2002.

22.06.2018

The following new PIC/S Guidance documents have now been published on the PIC/S website:

  • PIC/S Aide-Memoire on “Cross-Contamination in Shared Facilities” (PI 043-1).
  • PIC/S Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (PI 045-1);
  • PIC/S Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (PI 046-1);
  • PIC/S Guidelines on the principles of Good Distribution Practice for active substances for medicinal products for human use (PI 047-1)
22.06.2018

On 19 June 2018 the European Medicines Agency (EMA) published

  • Revision 2 of its practical guidances for procedures related to Brexit for medicinal products for marketing authorisation holders (MAH) and
  • Revision 3 of the related Q&A document.

Both documents shall assist pharmaceutical manufacurers in preparing for Brexit.

15.06.2018

The US FDA is currently alerting patients, health care professionals and those involved in the drug supply chain of more than 16,000 packages of the injectable fertility medications Gonal-f RFF Redi-ject and Gonal-f Multi-Dosethat have been stolen in Italy.

 

15.06.2018

With the publication of the 52nd Technical Report Series No. 1010 of the WHO, eleven Guidelines were adopted and recommended for use:

08.06.2018

The US Food and Drug Administration (FDA) confirmed the capability of Lithuania and Ireland to carry out GMP inspections at a level equivalent to the US.

08.06.2018

The ICH Q3D(R1) Revision of the ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in May 2018 and now enters the consultation period. The revision is focused on an error correction in the calculation of the Cadmium inhalation Permitted Daily Exposure (PDE) level.

01.06.2018

On 23 May 2018, the European Medicines Agency (EMA) released a guideline laying out the principles for managing investigational medicinal products for use in a clinical trial and in accordance with Good Clinical Practices (GCPs) and Good Manufacturing Practice (GMPs) for public consultation.

01.06.2018

In May the US FDA has issued five Warning Letters that address cGMP-violations on a large scale. The drug facilities involved are:

  • Jilin Shulan Synthetic Pharmaceutical und Nox Bellcow Cosmetics Co, China
  • Jalco Cosmetics, Australia
  • Europharma Concepts, Ireland
  • Reine Lifescience, India.
22.05.2018

The UK government must secure a post-Brexit deal for the pharmaceutical industry that ensures the closest possible regulatory alignment with the EU and the minimum border friction possible or risk harming patients and seeing the pharma sector losing its status as a world leader, say the Business, Energy and Industrial Strategy Committee of the UK parliament.

14.05.2018

From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.

14.05.2018

The Danish Medicines Agency recently met with representatives from the Japanese Ministry of Health, Labour and Welfare (MHLW), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in Copenhagen.

02.05.2018

On 30 April 2018, the EMA published the final, revised version of the Q&A document with its focus on setting health-based exposure limits for risk identification and the risk-based prevention of cross-contamination. The Q&A covers 13 questions and answers relating to the “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”, which has been in force since June 2015.

In January 2017, the EMA released a draft for public consultation (we reported). But this paper constituted a roll backwards!

02.05.2018

On Tuesday, 27/4/2018, MHRA (Medicines and Healthcare products Regulatory Agency) published is five-year Corporate Plan for 2018 - 2023.

02.05.2018

The European Medicines Agency (EMA) and the Netherlands have finalised the text of a Seat Agreement which describes how the Agency, its bodies and its employees will be treated by the Dutch once they start operating in the Netherlands.

20.04.2018

In July 2016, the Pharmaceuticals and Medical Devices Agency (PMDA) established the Innovative Manufacturing Technology Working Group (IMT-WG) as part of the “Projects Across Multi-Offices” in PMDA. The IMT-WG launched activities to examine desirable regulations that streamline the introduction of new manufacturing technologies, and selected continuous manufacturing as their primary target.

20.04.2018

Almost one year ago, the ICH published its Guideline for Residual Solvents in the version ICH Q3C (R6) introducing new PDE-Levels for Triethylamine and Methylisobutylketone.

20.04.2018

The FDA (US Food and Drug Administration) finalised the ICH Q7 Q&A Guidance on GMPs for APIs on Thursday April 19, 2018.

17.04.2018

With an increasing globalisation of medicine manufacturing and supply chains, regulatory authorities across the world consider themselves responsible to cooperate in the overall interest of public health. Pharmaceutical companies that are outsourcing their production of APIs to contract manufacturers located in other countries have led to an increased need for inspections, to ensure adequate oversight of these facilities

17.04.2018

The WHO has released three interesting documents on its website for public comments:

06.04.2018

On 3 April 2018, the EMA has published a 4-page public consultation document concerning the European Union template for GMP non-compliant statement. The GMP/GDP Inspectors Working Group is currently discussing possible actions required if inspections conclude with serious GMP non-compliance when at the same time this conclusion would block the availability of life-saving medicines. “What happens when?” is the question that EMA is now putting up for public discussion.

03.04.2018

At the International Conference on Medical Device Standards and Regulations in Arlington VA, hosted by the AAMI (Association for Advancement of Medical Instrumentation), experts discussed the upcoming regulatory changes occurring with the new European regulations on medical devices (MDs) and in vitro diagnostics (IVDs). They urged the companies to prepare for these changes because it is likely that the medical device industry needs to invest a lot of time and resources to prepare for and comply with the upcoming requirements when it comes to trading goods with the European industry or manufacturing in the EU.

23.03.2018

The German BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) published a statement about counterfeit CellCept® 500 mg film-coated tablets on March 14, 2018. The medicinal product which is manufactured by Roche Reg. Ltd., is used to avoid rejection reactions after transplantations.

23.03.2018

The European Medicines Agency (EMA) discussed the following points at its 15 March meeting in London:

20.03.2018

Two years after the release of a draft data integrity document, the British MHRA published the final version of its GxP data integrity guide on March 9, 2018. Data integrity (DI) is important throughout the pharmaceutical lifecycle.

13.03.2018

The US Food and Drug Administration (FDA) released two warning letters sent to over-the-counter (OTC) drugmakers in China and Hong Kong and a third one to a drug manufacturer in the USA. In addition, two Form 483s for India-based Sun Pharmaceutical Industries and Aurobindo Pharma were released.

13.03.2018

While Theresa May promoted the benefits of the UK becoming an associate member of the EMA, the EU took quite an opposite position. In a draft guideline published on 7 March 2018 the EU sets out how the EU council sees its future with the UK. A comment by the British newspaper “The Guardian” states that while the British government does Brexit by speeches the EU prefers releasing documents.

02.03.2018

On 1 March 2018, the FDA listed four additional recognised authorities under Article 7 of the Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs). This confirms the capability of the following four European Member States to carry out GMP inspections at a level equivalent to the US:

02.03.2018

The MHRA has updated its interesting guidance on how to handle OOS results. The issue faced when dealing with “Out of Specification” results is always a challenge. Many customer requests we receive address this issue.

28.02.2018

The European Medicines Agency EMA has published the adopted 2018 Work Plan for the GMP/GDP Inspectors Working Group. The 8-page document lists, inter alia, new guidance documents and also guidance documents to be revised within the EU GMP Guide. According to the EMA, the plan has been agreed in view of preparing for the relocation of the agency to Amsterdam and is, therefore, subject to further review and reprioritisation.

 

16.02.2018

Following the Commission Report on Member State penalties for falsification (we reported) the European Commission has released a Questions and Answers document alongside this topic (Version 9) on 13 February 2018. The document addresses an overall of 90 frequently asked questions regarding the implementation of the rules on the safety features for medicinal products for human use. These rules are enshrined in Articles 47a, 54(o) and 54a of Directive 2001/83/EC, and in the Commission Delegated Regulation (EU) No 2016/161. They will become mandatory in February 2019.

13.02.2018

The British MHRA (Medicines and Healthcare products Regulatory Agency) and the China Food and Drug Administration (CFDA) signed a Memorandum of Understanding (MoU) on 1 February 2018

13.02.2018

The European Commission (EC) has published a report that takes a closer look at the implementation of the Falsified Medicines Directive 2011/62/EU in the European member states which

  • introduces mandatory safety features on prescription medicines from February 2019 on
  • strengthens good distribution practices and requirements for wholesale distributors
  • reinforces rules on importation, controls and inspections of active substances and their manufacturers, and
  • established an EU-wide logo to allow the identification of legal online retailers of medicines (as of 1 July 2015).
06.02.2018

The European Medicines Agency released two updated documents for ATMPs (Advanced Therapy Medicinal Products) on 1 February 2018:

26.01.2018

The MHRA (Medicines and Healthcare products Regulatory Agency, UK) has published an update on the negotiations between the EU and the UK which have now entered the second phase.

26.01.2018

The European Medicines Agency (EMA) has launched a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health.

23.01.2018

The U.S. Food and Drug Administration (FDA) published the yearly list of new and revised draft guidances, CDER is planning to release in 2018. A total of 98 planned guidance documents have been set out which are categorised in 18 different themes.

19.01.2018

This week the US FDA (Food and Drug Administration) has already released five warning letters, all dealing with significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and APIs. Following is a short summary of the various findings:

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