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Focus on Regulation

Category Archives: Pharmaceutical & Biotechnology

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Italy approves new provisions on informed consent and advance decision of medical treatments – Why it matters for clinical trials in emergency situations

On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the future (so-called advanced decision, sometimes also referred to as living will, and translated as “Biotestamento” in Italian ). Advanced decision of

Draft Fee Regulations – Attempts to Address Incentivising Loopholes

Section 18A of the South African Medicines Act (the “Medicines Act“) prohibits the supply of any medicine, medical device or in-vitro diagnostic device, according to a bonus system, rebate system or any other incentive scheme. Although no definitions in respect of these prohibited activities have been included in the Medicines Act, considerable guidance as to

New Legislation Increases Access to Medical Products for Military Applications

Today, the President signed new legislation that gives the Department of Defense (DoD) new opportunities to advocate to FDA for expedited development, review, and Emergency Use Authorization (EUA) for medical products that could help protect and treat U.S. military forces.  The legislation was developed as an alternative to a provision in the National Defense Authorization

UK Government Announces Life Sciences Sector Deal

The UK government has published a White Paper setting out its new Industrial Strategy and, as part of that strategy, has agreed a Sector Deal with the UK life sciences sector. The White Paper covers all industries and identifies the life sciences sector as having particular strategic value in the UK, generating £64 billion of

FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited programs available for the development and review of certain regenerative medicine therapies.  Importantly, the draft guidance clarifies certain aspects of the Regenerative Medicine Advanced Therapy (RMAT) designation established by

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

Yesterday, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies.  This initiative builds on the agency’s existing framework to set forth more clearly which products are subject to regulatory enforcement. In September, as we previously discussed here and here, FDA’s Commissioner,

New rules for expanded access in Italy

Fast track for orphan diseases and rare forms of cancers By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd  November2017, the Ministry of Health enacted new rules on expanded access to medicinal products, for which the authorisation procedure is still on-going, replacing the former Ministerial

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

Earlier today, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of [pharmaceutical] manufacturing facilities that meet FDA requirements,” and that the Agency will begin relying “on the inspectional data obtained by these eight regulatory agencies” immediately. 

FDA Simplifies and Clarifies Expanded Access Program

Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program.  Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment with an investigational product when there is no therapeutic alternative.  In particular, FDA made three announcements: FDA has decided that physicians requesting individual patient

FDA Launches New Tool For Accessing Drug Adverse Event Information

FDA recently launched a public dashboard within the FDA’s Adverse Event Reporting System (FAERS) to improve access to data on adverse events related to drug and biological products.  FDA Commissioner Scott Gottlieb, M.D. stated, “Tools like [FAERS] are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and

EMA’s reply to the EU Ombudsman inquiry on pre-submission interactions with medicinal product developers

The European Medicines Agency (“EMA”) has replied to a letter from the European Ombudsman opening a strategic inquiry into EMA’s pre-submission activities. Background information On 17 July 2017, Emily O’Reilly, the European Ombudsman, decided to conduct a strategic inquiry concerning EMA’s arrangements with individual medicinal products developers prior to the submission by these developers of

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate Sterility Assurance

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning letter issued to U.S. Stem Cell Clinic located in Sunrise, FL.  FDA issued the warning letter following an inspection beginning in April

The life sciences industry under the antitrust spotlight in China: two practical points

The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement decision was announced against a government entity, a local health commission, for breaching a number of provisions in the Anti-Monopoly Law (AML).

EMA updates guidance concerning medicinal products intended exclusively for non-EU countries

The European Medicines Agency (“EMA”) has updated its guidance (Guidance) regarding procedural advice for medicinal products intended exclusively for markets outside the European Union (“EU”). The Guidance addresses several questions which applicants requesting a scientific opinion as provided in Article 58 of Regulation (EC) No 726/2004 (“Article 58”, the “EMA Regulation”) may have. Article 58

Unburden Yourself: FDA Requests Comments on Ways to Implement President Trump’s Regulatory Reform Executive Orders

Earlier this year, in an effort to alleviate unnecessary regulatory burdens, President Trump issued two executive orders, Executive Order 13771, Reducing Regulatory and Controlling Regulatory Costs and Executive Order 13777, Enforcing the Regulatory Reform Agenda. On September 8, 2017, FDA published several notices in the Federal Register, to implement these orders, soliciting comments from the

EMA released reflexion paper clarifying information related to the selection of starting materials

The European Medicines Agency (“EMA”) has released a reflexion paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances. The reflexion paper provides clarification with respect to Section 5 of ICH guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). This Section