Regulations in the US and EU Dealing with Combination Products

Regulations in the US and EU Dealing with Combination Products.jpg

Registering and maintaining combination products in the US and the EU is a bit tricky, because these are disparate markets that are governed by different sets of regulations which are independent of each other. So, any business that wants to market combination products into the US or the EU must be completely aware of the nature and meaning of all the regulations. Such businesses need to understand the nuances of the regulatory expectations and do what it takes to meet these.

Professionals and organizations that work in these areas must familiarize themselves with the existing regulations and their latest updates. This is the foundation to ensuring that their products comply with regulatory requirements and meet quality standards, which ensures that the consumer consumes products that are of the set scientific standards.

The regulations in the two markets have evolved differently. The fact that the regulatory agencies in the two markets, namely the US FDA and the European Medicines Agency (EMA) work to ensure the quality of drugs and thus the wellbeing of their consumers is the commonality between the two.

While the US FDA is a centralized agency that regulates food and medicinal products across the vast US market; the EMA, synchronizes the regulations of the 28 countries that are members of the European Union. While the FDA was primarily created to be a consumer protection agency; the regulations from the EMA came about to harmonize the commercial and technological interests of the Member States.

The EU’s new update

Regulations in the US and EU Dealing with Combination Products 3.jpg

In September 2016, the EU, through its two major legislative organs -the European Commission and the European Council, reached a compromise on a major area concerning combination products. Reached four years after a deal was made; the compromise relates to medical devices and invitro diagnostic (IVD) devices.

High risk combination devices, such as implants, will from now be assessed and authorized by the EMA. Brought in to replace the existing EU legislation on medical devices and in-vitro diagnostics; the new regulation seeks to make these products more consistent and uniform in terms of their assessment and approval process across the EU.

Thorough and sound learning of the US and EU regulations on combination products

This is the case of just one regulation in the EU concerning combination products. When the regulations and their updates from both the US and the EU are taken together, a regulatory professional or anyone in manufacturing is up against a mountain. It is to help gain clarity on this wide array of topics that GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day seminar.

This seminar, which is aimed at giving professionals who work in areas concerning regulation in the combination products area, will have Salma Michor, founder and CEO of Michor Consulting Schweiz GmbH, as the Director.

Please visit Regulations in the US and EU Dealing with Combination Products to register for this seminar. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Clarity about combination products

Regulations in the US and EU Dealing with Combination Products 1.jpg

Over two days of intense learning, Salma will offer a thorough understanding of the complexities involved in the regulations about combination products in the EU and the US. She will offer in-depth explanation of all the relevant regulations and guidelines. She will reinforce this learning by offering real life examples of how to register and maintain various types of combination products.

Salma will also help participants explore Interfaces, at which Change Management and LCM will be taken up for explanation. Other important aspects relating to the subject of combination products, namely compliant safety reporting for combination products and documentation requirements and interfacing, will be described in detail at this session.

Over the two days of intense learning, Salma will cover the following areas:

Documentation requirements and interfacing

Regulations in the US and EU Dealing with Combination Products 4

  • Documentation requirements for combination products EU
  • Documentation requirements for combination products US
  • Interfacing, development, quality, regulatory
  • Managing third parties and document control.

This seminar is of high value to professionals whose work is related in one or another way to combination products, such as Regulatory Affairs, Medical Officers, and Clinical Trial Managers.

click to continue reading

 

 

Orkambi Reduces Main Biomarker of CF, Vertex Says in Updated Results on Four Therapies

Orkambi Reduces

Orkambi (lumacaftor/ivacaftor) reduced levels of the main biomarker of the lung disease cystic fibrosis and improved the nutritional status of children with the condition, according to a Phase 3 clinical trial.

The results were part of a recent update that Vertex Pharmaceuticals provided on Orkambi and three of its other CF therapies, Kalydeco (ivacaftor), tezacaftor (VX-661) and VX-371.

Vertex conducted the Phase 3 trial (NCT02797132) of Orkambi to evaluate its effectiveness and safety in preschoolers with two copies of the CFTR gene’s F508del mutation. The 60 children were aged 2 to 5. Mutations of the gene cause CF by producing faulty versions of the CFTR protein.

An indication of Orkambi’s effectiveness in the trial was that it reduced the production of the children’s sweat chloride and improved their nutritional status.

A sweat test is the gold standard for diagnosing CF because people with the disease have more chloride in their sweat than those who don’t. As for nutrition, the thick mucus that CF produces in the digestive system can prevent patients from absorbing nutrients and fat properly, leading to difficulty gaining weight and slower growth. CF also produces the mucus in lungs and other organs.

The Phase 3 trial also showed that Orkambi was safe and that the children tolerated it well. Researchers reported no adverse events besides those seen in studies of patients aged 6 to 11.

Based on the promising results of the trial, Vertex plans to submit a New Drug Application on Orkambi to the U.S. Food and Drug Administration during the first quarter of 2018. It will also ask the European Medicines Agency to extend the therapy’s availability to very young children.

Another Phase 3 trial (NCT02412111) that Vertex conducted evaluated a combination of tezacaftor and Kalydeco’s ability to reduce respiratory problems in patients more than 12 years old.

The study included 151 participants at 68 sites in the United States, Canada, Australia, and the European Union. The patients had one copy of the F508del mutation and one copy of another CFTR mutation.

Eight weeks of treatment with the combo led to a negligible improvement in a measure of patients’ lung function known as forced expiratory volume in one second, or FEV1. This is the amount of air that people can forcefully blow out of their lungs in one second.

The combo did lead to a reduction in sweat chloride that was larger than Kalydeco generated alone, however.

Given the results, Vertex has decided not to continue pursuing regulatory approval for the combo. One reason is that most patients older than 12 are eligible to receive Kalydeco by itself.

The FDA is expected to make a decision by February 2018 on a related New Drug Application that Vertex has filed. That application involves using the tezacaftor-Kalydeco combo to treat patients aged 12 or older who carry two copies of an F508del mutation or one copy of an F508del mutation plus another mutation. The FDA is giving the request priority review.

European regulators are expected to decide whether to approve the combo therapy in the second half of 2018.

Vertex has completed enrolling children 12 to 24 months for another Phase 3 trial (NCT03277196) of Kalydeco. It will evaluate the therapy’s safety in children less than 2 years old with a CFTR gating mutation and an R117H mutation.

To continue reading

Drugstore stocks tumble as Amazon considers selling prescription drugs online

Drugstore stocks tumble as Amazon considers selling prescription drugs online

Shares of drugmakers dropped in midday trading Friday after CNBC reported Amazon is in the final stages of considering an entrance into selling drug prescriptions.

Walgreens, Rite Aid and CVS Health stocks each slipped 4 percent or more as investors worried Amazon may disrupt the traditional distributors’ hold on the drug prescription market.

Amazon will decide before Thanksgiving whether to move into selling prescription drugs online, according to a source and an email from Amazon viewed by CNBC.

Amazon typically spends years researching opportunities before it telegraphs its intentions. The opportunity to sell drugs online is alluring given its market size – analysts have estimated the U.S. prescription

 

Read More: http://snip.ly/j7tf0#https://www.cnbc.com/2017/10/06/drugstore-stocks-tumble-as-amazon-considers-selling-prescription-drugs-online.html

Four years of the EU’s Cosmetics Product Regulation

It has been four years since the EU’s Cosmetics Product Regulation (Regulation EC No. 1223/2009), initiated in December 2009, became operational in July 2013. This regulation was considered path breaking when it was introduced because of its comprehensive nature as well as the extent of the shift it signaled from the legislation from which it took off. It was also considered extremely significant because it suggested a regulatory framework that was in alignment with the most modern technologies and methods available during the present times.

Some of the regulatory modules which are structured into the EU’s Cosmetics Product Regulation include important elements aimed at ensuring safety of cosmetic products and accountability from manufacturers, and include points such as:

o  Cosmetic Product Safety Report (CPSR)

o  Product Information File (PIF)

o  Responsible Person (RP)

o  Label information

o  Cosmetovigilance

o  Substance regulations

o  Claims, etc.

Compliance with the safety regulations set out in EU’s Cosmetics Product Regulation is mandatory. This, though, is not easy, considering the severe clauses that the regulation has for ensuring compliance. These are the reasons for which compliance with the EU’s Cosmetics Product Regulation is challenging:

–       In-market control is assigned to EU Member State competent authorities

–       The flow of information between countries is interlinked by the Cosmetic Product Notification Portal (CPNP), which is fed with the information by the demand for pre-market notification of cosmetic products and by ongoing cosmetovigilance procedures put in place with the respective provisions in the CPR

–       The central role in cosmetovigilance applies to the Responsible Person while the access to manufacturers and responsible persons is assured by product labeling provisions

–       EU and non-EU manufactures of cosmetics as well, as the suppliers of cosmetic ingredients, are required to provide data on their chemicals

–       Compliance with the modules requires know-how, diligence and ongoing adjustment to state of the art of knowledge and documentation.

More challenges

In addition, the EU’s Cosmetics Product Regulation presents more challenges for manufacturers of cosmetic products that want to market to any of the countries of the EU:

The EU’s Cosmetics Product Regulation is so expansive that it represents not only the entry requirements for marketing of cosmetics product in the European Union; but is a model framework for many national legislations worldwide. These legislators are given the choice of either adopting a few parts of the EU’s Cosmetics Product Regulation’s modules, or the structure of the Regulation of its predecessor legislation, the Cosmetics Directive, in full. Therefore, companies need to have the knowledge and the skills needed for complying both with the EU’s Cosmetics Product Regulation and other regulatory frameworks.

There is yet another challenge to implementing the EU’s Cosmetics Product Regulation: The safety assessment. Complying with this part of the EU’s Cosmetics Product Regulation requires extensive knowledge and skill of a host of subjects and issues such as toxicology, chemistry, cosmetology and microbiology, apart from that of regulatory affairs and compliance management. This already tough provision has been made even tougher with the final implementation of the ban on animal testing that the EU introduced in March 2013,

As a result of this ban, considerable confusion abounds about the interpretation of the compliance regulations in the various agencies and sectors that the compliance process has to pass through. If alternative tests are carried out, they are not available for all toxicological endpoints that need assessment as part of the EU’s Cosmetics Product Regulation.

Clearing the confusions

This makes compliance with the EU’s Cosmetics Product Regulation as difficult and complicated as one can imagine. A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer clarity on the provisions of the EU’s Cosmetics Product Regulation. The complicated parts of the regulation, namely the regulatory modules, will be given a clearer understanding.

The Director of this two-day seminar is Dr. Annelie Struessmann, who is the Technical & Regulatory Director with CONUSBAT Regulatory Services, a provider of internationalization compliance services for Cosmetics, Personal Care, Fine Chemicals and Borderline Industries.

To gain better understanding of this regulation, please visit Four years of the EU’s Cosmetics Product Regulation to enroll. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

At this session, Dr. Struessmann will explain the provisions of the regulatory modules and supplement this with a description of the latest developments and research results. She will use these to show pathways towards compliance, at which she will use practical examples and experiences gained in the course of performing the necessary compliance steps before and while marketing of cosmetics products in the EU.