EMA: Public Consultation on GMP Non-compliance Statement
US experts call for early preparation for European MDR, IVDR and what about 21 CFR 820?
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.
Counterfeit Drugs on German Market
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.
EMA Management Board: Highlights of the March 2018 Meeting
The European Medicines Agency (EMA) discussed the following points at its 15 March meeting in London:
MHRA: „GxP Data Integrity Guidance and Definitions“ now final
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.
FDA Warns OTC Drugmakers in China and Hong Kong, Drug Manufacturer in the US, Sends 483s to Aurobindo and Sun
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.
Will the UK Be Part of EMA After Brexit? –EC and UK Follow Different Approaches
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.
EU/US: MRA on Inspections – Four More Member States Added
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:
MHRA: Out of Specification Guidance
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.
EMA Publishes Work Plan for the GMP/GDP Inspectors Working Group
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.
New Q&A on safety features concerning falsified medicines
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.
UK and China Sign Memorandum of Understanding
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
EC: Report on Transposition of Falsified Medicines Directive
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).
EC/EMA: New Guidelines on ATMPs
The European Medicines Agency released two updated documents for ATMPs (Advanced Therapy Medicinal Products) on 1 February 2018:
MHRA: No Sudden Changes to Regulatory Framework
EMA: Survey for Pharma Companies on Brexit-Preparedness
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.
CDER List for Planned Guidance Documents in 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.
FDA Warning Letters to Chinese, Australian and Austrian Drugmakers
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:
Swissmedic updates Biosimilar Guidance and FAQs
Swissmedic has announced that as of now, the foreign comparator product with a biosimilar for the main studies can also originate from the USA, while that for supplementary studies can now also originate from Canada.
India reports quality shortcomings of Chinese pharma companies
The Economic Times of India has published an article saying that the Indian government has issued showcause notices to eight Chinese pharmaceutical companies. Those companies were inspected by a special Indian inspection team and were found to supply poor quality APIs to drug manufacturers in India.
EC: Draft to Annex 1 on Sterile Manufacturing Published
On 20 December 2017 the European Commission has published the long awaited draft of Annex 1 “Manufacture of Sterile Medicinal Products”. The public consultation period is open from 20 December until 20 March 2018.
Draft of ICH Q12 to Pharmaceutical Product Lifecycle
EMA and EC: Update of Brexit Q&A for pharma industry
The EMA (European Medicines Agency) and the European Commission have published an updated version of the Q&A document which is intended to help the pharmaceutical industry to organise the UK’s withdrawal from the EU for their company.
EMA publishes further guidance to prepare for Brexit while industry groups call for transition period
Switzerland Revises Medical Devices Legislation
According to the Swiss Federal Office of Public Health FOPH, Switzerland is revising its medical devices legislation, closely modelled on the various new EU requirements aiming at an improvement on the safety and quality of medical devices.
EC/EMA: Final Guidelines on GMP for ATMPs
European Medicines Agency EMA moves to Amsterdam
The city to host the new headquarter of the European Medicines Agency EMA is chosen. Amsterdam emerged as the winner ahead of Milan and Copenhagen, the two other cities that reached the second and final round.
EU-GMP Annex 16: Official German Translation Published
The German Federal Ministry of Health “Bundesministerium für Gesundheit, BMG” has published the official German translation of Annex 16: Certification by a Qualified Person and Batch Release, which is part of the EU GMP Eudralex Volume 4 GMP guidelines.
Purified Water Monography: New Draft in European Pharmacopoeia 9.4
A draft of the monography to Purified Water was published in the European Pharmacopoeia, which includes a new section on Elemental Impurities.
EU-US Mutual Recognition of Inspections Enters Operational Phase
As of 1 November 2017, the Mutual Recognition Agreement (MRA) between the European Union and the United States enters the operational phase. The MRA, which will allow to recognise inspections of manufacturing sites for human medicines conducted in each partners’ respective territories shall update the agreement dating back to 1998.
EMA publishes Brexit Preparedness Plan
On 16 October 2017, the EMA (European Medicines Agency) has published its 17-page Business Preparedness Plan to ensure continuity of the Agency’s operations once the United Kingdom is no longer a member country of the European Union.
The plan identifies three main priorities:
- Not to jeopardise EMA’s positioning in the pharmaceutical arena in the post-Brexit era.
- In parallel, to demonstrate its preparedness for addressing any emerging consequences by taking decisive and timely action when needed.
- To provide a balanced communication and full transparency, both internally and externally.
Swissmedic: Changes in Cross-border Inspections
According to Swissmedic, the new Article 64a of the revised Therapeutic Products Act (revTPA) will already enter into force on 1 January 2018. This Article governs cross-border inspections and includes inspections carried out in Switzerland by foreign authorities, as well as inspections by Swiss authorities abroad.
"Operation PANGEA X": 10th and largest operation against illicit online pharmacies
Between 12 and 19 September 2017, authorities around the world targeted the illicit online sale of medicines and medical devices. More than 123 countries took part in Operation PANGEA X which led to a record number of 25 million illicit and counterfeit medicines seized worldwide.
EMA: How can a GMP non-compliance statement be lifted?
The European Medicines Agency EMA has clarified its process for lifting a GMP non-compliance statement. The new process is outlined in an update to the question and answer document on GMP of the EMA.
FDA seeks input on “Continuous Manufacturing”
On September 11, 2017, Michael Kopcha, Ph.D., R.Ph. and FDA’s director of the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER), announced the opening of a public docket to seek input from experts in areas of science, technology and best practices concerning “Continuous Manufacturing”. To establish common guiding principles to this new technology shall help to push this production method forward.
Short news: PIC/S / Swissmedic
PIC/S: Three New Participating Authorities
Swissmedic: Combat Against Illegal Pharmaceuticals
CDRH Releases Eight Warning Letters for Device Manufacturers From Around The World
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) published a whole new round of warning letters. They are addressed to three manufacturers from the US and five in Brazil, the Netherlands, Germany, China and Bulgaria.
ICH Q11 Q&A reaches Step 4
According to the ICH (International Council for Harmonisation), the ICH Q11 Q&A reached Step 4 of the ICH process in August 2017. The document is now entering Step 5 – the implementation period.
British MHRA busy with Brexit
The British Medicines and Healthcare products Regulatory Agency (MHRA) is dealing with the outcome of the EU referendum to move things into the right direction for the post-Brexit period.
EMA and FDA: Sharing of Commercially Confidential Information
The European Medicines Agency EMA, the European Commission and the US FDA have signed a new confidentiality commitment. It enables US and EU regulators to share non-public and commercially confidential information, including trade secret information relating to medicine inspections.
Applications to host EMA Headquarters
The European Medicines Agency (EMA) is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The agency will need to be relocated in the context of the UK's withdrawal from the EU. There have been 19 offers to host the European Medicines Agency (EMA).
India: Draft Guidance on Safety and Performance of Medical Devices
The government of India has published a draft document on the „Essential Principles for Safety and Performance of Medical Devices“, e.g. fundamental design and manufacturing requirements. It provides an overview on meeting these principles leaving flexibility to the manufacturers rather than dictating how a manufacturer should prove that the essentials laid down are being met.
Expansion of MRA between Japan and EU
WHO: Technical Report Series 1003 published
The WHO Expert Committee on Specifications for Pharmaceutical Preparations has recently published its 51st report (Technical Report Series No. 1003). The WHO Technical Report Series covers the findings of various international groups of experts that provide WHO with the latest scientific and technical advice on medical and public health subjects. TRS No. 1003 summarises the outcome of the Expert Committee Meeting of October 2016 in Geneva. In addition, the 252-page report contains all adopted guidances or draft guidances in the form of Appendices.
Joint pharma venture planned between India and Russia
According to pharmabiz.com, India is planning to set up a joint pharmaceutical venture in the region of Chelyabinsk in Russia and is now seeking views and suggestions from its pharmaceutical industry. On July 17, a interactive meeting with government senior officials and industry leaders will take place.
Swissmedic: Implementing of the Therapeutic Products Act Packet IV
As a result of the revised Swiss Therapeutic Products Act of March 2016, the relevant ordinances also need to be comprehensively adjusted. This affects ordinances issued both by the Federal Council and the Agency Council of Swissmedic and will last until October 2017.
EMA: Decision on Relocation in November
The European Council has published a timetable for the relocation of the Euorpean Medicines Agency (EMA) that is currently based in London.
FDA: Revision of Draft on cGMP for Medical Gases
FDA: Draft Q&A to Electronic Records and Signatures in Clinical Investigations – 21 CFR 11
ICH: CFDA new member, PIC/S new observer
According to ICH, the China Food and Drug Administration (CFDA) has been approved as a new Regulatory Member.