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:
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.
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.
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.
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
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).
The European Medicines Agency released two updated documents for ATMPs (Advanced Therapy Medicinal Products) on 1 February 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.
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.
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 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.
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.
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.
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.
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.
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.
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.
A draft of the monography to Purified Water was published in the European Pharmacopoeia, which includes a new section on Elemental Impurities.
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.
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.
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.
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.
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.
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.
PIC/S: Three New Participating Authorities
Swissmedic: Combat Against Illegal Pharmaceuticals
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.
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.
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.
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.
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).
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.
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.
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.
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.
The European Council has published a timetable for the relocation of the Euorpean Medicines Agency (EMA) that is currently based in London.
According to ICH, the China Food and Drug Administration (CFDA) has been approved as a new Regulatory Member.
According to a press release by the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, the German Federal Institute for Drugs and Medical Devices), a counterfeit pack of Gilead Sciences’ hepatitis C drug Harvoni® has entered the legal supply chain in Germany. The “falsified medicinal product” was identified by a patient who noticed a change in colour which was orange instead of white.
The China Food and Drug Administration (CFDA) released a detailed report on inspections conducted throughout the last year. A total of 431 inspections including pre-approval inspections, GMP certification inspections, GMP follow-up inspections, unannounced inspections, overseas inspections, GSP unannounced inspection and inspection observations are analysed therein.
According to the Swiss Therapeutic Products Agency Swissmedic, the agency achieved its objectives last year. Regulatory approval was granted for more than 40 innovative medicinal products partially due to a fast-track procedure.
In collaboration with APEC (Asia Pacific Economic Cooperation), the US FDA has created a Supply Chain Security Toolkit for Medicinal Products. The intention behind this new tool is to maximize available global resources and to deliver quality trainings and best practices in order to secure the global supply chain. It covers the entire supply chain and lifecycle from raw materials to use by patients.
In January 2017, the FDA issued the long-awaited Biosimilar Interchangeability Guidance for public consultation. In this guidance, the Agency details its expectations for demonstrating biosimilar interchangeability.
The deadline for commenting the draft guidance ended on 19 May, with a number of 45 comments being received. Comments came from big pharmaceutical manufacturers like Pfizer, Boehringer Ingelheim, Sandoz, Johnson and Johnson or Genentech or from organisations, e.g the American Society of Clinical Oncology, the Academy of Managed Care Pharmacy, the Combination Products Coalitions or the Biosimilars Forum.