Author: Frank LUGAN

ANSM injunction: how to react? In France, ANSM (Agence Nationale de Sécurité du Médicament)  is the authority responsible for protecting public health. If a any risk would threats this one, the potential harm caused by a failure in the drug manufacturing chain, the manufacturer concerned receives an ANSM injunction. These must be treated seriously, as they can have significant repercussions for a pharmaceutical company. In addition to the risks to reputation and consumer confidence, failure to comply with regulatory requirements can lead to severe legal consequences, including fines and suspension of marketing authorisation. It is therefore imperative for companies to act swiftly to safeguard the quality and compliance of their products. This article guides you through the essential steps you need to take to respond to an animal health decision and ensure your company’s compliance with regulatory standards. Reply to the ANSM advance letter On receipt of the preliminary inspection report (or a letter prior to the ANSM injunction), the offending company enters what is known as the contradictory period. During this phase, it is essential to manage communication with the inspection body effectively, responding fully and within the time limits set. The response must be carefully drafted, firstly describing the precautionary measures put in place prior to compliance. Secondly, the operator must provide precise information and present a clear action plan to remedy the shortcomings identified. This letter also provides an opportunity to express any objections or comments on the health decision.The ANSM then assesses the resources and protective measures taken to ensure that the corrective measures are appropriate and effective. If the solutions are sufficient, the injunction will not be adopted. If not, the company will be notified. Responding to the injunction by building an action plan The probationary period mentioned in the injunction takes effect on the day of notification of receipt of the injunction. At the same time, the document is also published on the national regulator’s website for public access. During this phase, it is essential to set up milestones to monitor progress towards compliance. For example, it is advisable to : conduct an internal audit; identifying gaps improving procedures applying best practice; train staff; strengthen quality control strengthen validation and qualification introduce traceability; implement a monitoring and continuous improvement procedure… The various possible outcomes of an injunction must be taken into account, whether they be regularisations, maintenance after the last deadline, cancellations or partial extensions. Once the action plan has been implemented, the operator must provide proof of compliance during a new inspection. This will determine how the rest of the procedure will proceed. LUGAN CONSULTING: EXPERTISE IN PHARMA PROCESSES Call on our experience to help you set up an action plan to comply with an ANSM injunction. Contact us Impact of an ANSM injunction Once the probationary inspection has been completed, the regulator may : Either declare that compliance has been fully achieved, in which case the injunction will be lifted. Or decide that insufficient action has been taken, and issue a formal notice. Failure to comply with a complete procedure leads to two types of penalty: Financial penalties They are applied in cases where the manufacturer fails to fulfil one of its obligations or repeats a fault. It should also be noted that they can be combined with any penalty payment, but not with criminal proceedings. Criminal penalties In the event of non-compliance with a public health order or where human health is directly endangered, the regulatory authority may assert non-compliance with the public health code and decide to take the company to criminal court. Faced with injunctions from the ANSM, responsiveness and vigilance are essential for pharmaceutical companies. By working closely with the regulatory authorities, companies can maintain the quality and compliance of their products, while preserving consumer confidence and ensuring public safety. By adopting a proactive and transparent approach, companies can turn regulatory challenges into opportunities for continuous improvement and sustainable growth. FACING AN ANSM INJUNCTION? Contact our services. LUGAN CONSULTING offers a comprehensive range of consulting, auditing, coaching and training services dedicated to the pharmaceutical industry. Contact us Source : ANSM : Décisions (Lignes directrices relatives aux suites d’inspection) Frank LUGAN PHARMACEUTICAL QUALITY EXPERT Autres infos Decarbonisation of pharmaceutical companies: how to get started? Décarbonation des entreprises pharmaceutiques : quelles pistes suivre pour l’initier ? Data Integrity : 8 steps to becoming compliant Intégrité des données : 8 étapes pour se mettre en conformité Pharmaceutical audit L’audit interne dans l’industrie pharmaceutique Team building : secret of success Cohésion d’équipe : le secret du succès ANSM injunction : how to react ? Injonction ANSM : comment y répondre

THE DRUG MANUFACTURING PROCESS : FROM RESEARCH TO MARKET LAUNCH The pharmaceutical industry is a complex field in which the research, development and marketing of a medicine follow a rigorous path. There are many stages in this circuit , all designed to ensure the efficacy, safety and quality of the products that reach patients. Let’s take a look at how the drug manufacturing works, from conception to availability on pharmacy shelves. Research and testing: 8 to 10 years The first stage in the development of a drug is pharmaceutical research. It often begins with the identification of unmet medical needs in the treatment of a specific disease. Once these needs have been clearly defined, scientists embark on a relentless quest to discover new molecules or develop innovative treatments. Patent registration The research process can take years, and each discovery goes through rigorous stages. First, a patent is filed to protect the new compound or technology developed. Next, preclinical trials are carried out to assess the drug’s toxicity, pharmacokinetics and potential efficacy in animal models. Clinical tests Once pre-clinical results are satisfactory, drug candidates are selected, followed by clinical trials. These tests on humans are conducted in several phases to assess the efficacy and safety of the drug in patients. This stage can take several years and involve thousands of participants. Approvals and production start-up: 1 to 3 years Once the clinical trials have been completed and the results analysed, the drug manufacturer must obtain regulatory authorisation to market the product. The Marketing Authorisation Application (MAA) is submitted to the relevant authorities, such as the European Medicines Agency (EMA) or the Food and Drug Administration (FDA). Validation of the marketing authorisation dossier requires a full presentation of research data, the results of clinical trials, and information on the manufacture and quality control of the drug. Transparency is essential at this stage, with open communication on the risks and benefits of the drug. Once marketing authorisation has been obtained, the price and reimbursement of the drug are set, often in collaboration with public health bodies and insurance companies. The industrial manufacture of the drug then begins, following Good Manufacturing Practices (GMP) to guarantee its quality, safety and efficacy throughout the production process. Life of Medicines: 20 years and over A medicine begins its active life as soon as it is made available on the market. For approximately 20 years, the patent holder has exclusive marketing rights. It is only once this period has elapsed that the property right expires. From then on, other manufacturers can produce generic versions of the drug. The end of the patent often marks the start of a period of increased competition and lower prices, which can benefit patients by making treatments more accessible. However, generic manufacturers must also comply with strict standards, while offering effective alternatives to branded products. This complex journey requires an unwavering commitment to science, regulation and, above all, the health and well-being of patients. Every step of the way must ensure that the medicines that reach their hands are safe, effective and of high quality. CHALLENGES OF INDUSTRIALISATION France is experiencing a boom in pharmaceutical industrialisation. The challenges facing companies in this sector are numerous. LUGAN CONSULTING can help you manage change and implement good manufacturing practices, so that you have every advantage on your side. Contact us Frank LUGAN PHARMACEUTICAL QUALITY EXPERT Latest posts Data Integrity : 8 steps to becoming compliant Pharmaceutical audit Team building : secret of success ANSM injunction : how to react ? The drug manufacturing process : from research to market launch