Agency IQ

AUGUST 4, 2023

This past week, the MHRA provided guidance on labeling of medicines destined for Northern Ireland, with provisions to ensure that medicines only move into Northern Ireland market and don’t re-enter E.U. The European centralized marketing authorization procedure is no longer a valid medicines approval pathway for the U.K. member states.

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Agency IQ

AUGUST 23, 2024

BY Scott Stephens, MPA | Aug 19, 2024 9:33 PM CDT Background: classifying chemicals in the EU The EU uses the United Nations (UN) Globally Harmonized System (GHS) as the basis for classifying, labeling and packaging hazardous substances and mixtures. Currently, the CLP is aligned with the seventh revised edition of the GHS.

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Agency IQ

JUNE 7, 2024

The PPPR framework governs the authorization, sale, and use of PPPs, establishing a pre-market approval process for active substances – the pesticide components which control pests, weeds, and plant diseases – and for synergists and safeners before they can be allowed for use in PPPs.

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Agency IQ

APRIL 12, 2024

Additionally, reform package included revisions of the regulations for pediatric medicines and orphan drugs. Heated debates on the most contentious issues resulted in a compromise text for each legislation in March The proposal package , consisting of one directive and one regulation, was finally released in April 2023. citizens; 2.

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Agency IQ

SEPTEMBER 29, 2023

On October 5, the European Parliament (EP) plenary is scheduled to debate and likely vote on its position on the proposed regulation for reforming Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). food packaging, kitchen and tableware and food processing equipment).

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Agency IQ

JULY 12, 2024

In October 2024, the European Commission published a communication putting forth a package of reforms to address medicines shortages. Next, the European Commission collected data from marketing authorization holders, suppliers and national competent authorities for the selected medicines. Read AgencyIQ’s analysis of the non-paper.]

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Agency IQ

SEPTEMBER 22, 2023

It appears the issue is largely the result of unclear labeling for biocidal disinfectants, an aspect French regulators may flag in future market authorization evaluations for these products. Article 69 of the BPR regulates the labeling of all biocides, including biocidal disinfectants.

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Agency IQ

JUNE 17, 2024

This obligation to adhere to “self-regulation” (“Selbstkontrolle” in German) is laid out in Article 5 of ChemG and Article 26 of USG. see the explanatory document regarding Annex 3 in French) [ For more background, see AgencyIQ’s January 24 article. the authorization list).

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Agency IQ

NOVEMBER 3, 2023

Jan Schakwosky has introduced the No Toxics in Food Packaging Act of 2023, which seeks to ban the use of ortho-phthalates, per- and polyfluoroalkyl substances, bisphenol compounds, styrene, and antimony trioxide as food contact substances. No Toxics in Food Packaging Act of 2023 On October 26, 2023, Reps. Key Documents and Dates H.R.

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Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. Sections 5 – 9 are labeled as Part A and cover clinical evaluation considerations.

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Agency IQ

MAY 3, 2024

It amends the limit value for the presence of PBDEs in mixtures or articles. Proposal for Regulation Initiative entry Preventing terrorism – new rules on the marketing and use of high-risk chemicals Adoption was planned for Q3 2023 This initiative establishes rules on the marketing and use of high-risk chemicals.

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The Premier Consulting Blog

MAY 4, 2023

The global ophthalmic drugs market size was valued at $33.81 The new guidance provides detailed information to applicants and manufacturers regarding compliance with the requirements in 21 CFR Part 4 for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers. 2] On April 16, 2021, the U.S.

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Agency IQ

JUNE 21, 2024

For products that seek approval through the “centralized marketing authorization application,” the EMA’s Committee for Medicinal Products for Human Use (CHMP) conducts a scientific evaluation and issues a positive or negative opinion on whether an authorization should be granted. Conversely, authorization in specific E.U.

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Agency IQ

FEBRUARY 12, 2024

FDA and EMA re-launch parallel advice pilot for complex generics The path to market for complex generics and hybrid products is complicated, and regulatory harmonization efforts in this space are lacking. Getting a complex generic or hybrid medicine to market is challenging. Both agencies must grant the meeting request to move forward.

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Agency IQ

OCTOBER 27, 2023

aligns the rules with other EU chemicals legislation – notably on biocidal products and classification, labeling and packaging. It amends the limit value for the presence of HBCDD as an unintentional trace contaminant in substances, mixtures and articles. food packaging, kitchen and tableware and food processing equipment).

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FDA Law Blog: Biosimilars

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

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Agency IQ

JULY 26, 2024

Prior to CARES Act reforms, FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as they adhered to pre-set terms under the monograph. Read AgencyIQ’s explainer on the CARES Act here. What should be submitted to which portal?

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Agency IQ

NOVEMBER 27, 2023

The FDA estimated that the products containing the affected API had likely been on the market for about four years before this discovery. According to the last update, MHRA plans to align with international guidelines as far as possible, while communicating directly with marketing authorization holders about any diverging assessments.

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Agency IQ

FEBRUARY 2, 2024

Proposal for Delegated Regulation Initiative entry Draft act Persistent organic pollutants – hexabromocyclododecane (HBCDD) Adoption was planned for first quarter of 2022 This act amends the limit value for the presence of HBCDD as an unintentional trace contaminant in substances, mixtures and articles.

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Agency IQ

DECEMBER 1, 2023

For more background on the glyphosate authorization, see AgencyIQ’s October 12 article.] This measure will reduce the maximum PFOS concentration allowed as unintentional trace contaminant in substances, mixtures and articles and will remove the last specific exemption allowed in the EU since it is no longer needed.

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Agency IQ

MARCH 1, 2024

ECHA consultations under BPR closing in March BPR: Potential candidates for substitution These consultations support the evaluating competent authority in assessing the availability of substitutes or alternatives to active substances found to be potential candidates for substitution in accordance with Article 10 of the BPR.

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Agency IQ

NOVEMBER 3, 2023

Currently, only Article 23a and Article 81 of Directive 2001/83/EC address medicines supply across the E.U. The provision aims to ensure patient access to medicines where they have been marketed. Shortages Monitoring Platform established by Regulation (EU) 2022/123 Article 13 should be up and running by 2025.

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Agency IQ

DECEMBER 15, 2023

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation.

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Agency IQ

JUNE 7, 2024

The regulations increase focus on post-market requirements and expect continuous and instantaneous updates to all reports and documents when either the product or the benefit-risk ratio changes. The earliest a Notified Body could be designated to the MDR and IVDR was November 2017, according to MDR Article 123 and IVDR Article 113.

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Agency IQ

JANUARY 4, 2024

The Commission may be close to delivering this proposal , given that the EU executive recently adopted a package of related draft legislation in support of the CSS’s one substance-one assessment (1S1A) ambition. Two of the package’s proposed acts address the reattribution of tasks among EU agencies associated with chemical safety assessments.

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Agency IQ

MAY 31, 2024

It amends the limit value for the presence of PBDEs in mixtures or articles. Proposal for Regulation Initiative entry Preventing terrorism – new rules on the marketing and use of high-risk chemicals Adoption was planned for Q3 2023 This initiative establishes rules on the marketing and use of high-risk chemicals.

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Agency IQ

OCTOBER 27, 2023

Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes? policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024.

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Agency IQ

MAY 31, 2024

Even small changes in the Parliament’s composition could have an impact on ongoing legislative discussions, such as the revisions to the pharma reform package. The current European Parliament and Commission have confirmed their position on the pharma package, but the European Council is still working on its negotiation position.

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Agency IQ

JANUARY 26, 2024

FDA proposes first update to orthopedic device coating guidance since 1990s The FDA’s Center for Devices and Radiological Health (CDRH) has issued a new draft guidance specifically laying out the types of information it would want to see in pre-market submission for orthopedic devices with specific coating types.

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Agency IQ

MAY 3, 2024

The pharma reform package remains in E.U. In the interim, the European Council will continue to discuss the package, and stakeholders may gain some insight into the Council’s thinking near the end of May. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U. On April 10, the E.U.

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Agency IQ

JUNE 28, 2024

The bill originally defined “ product ” with a similar wide latitude, as “an item manufactured, assembled, packaged, or otherwise prepared for sale in California, including, but not limited to, its components, sold or distributed for personal, residential, commercial, or industrial use, including for use in making other products.”

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The Premier Consulting Blog

MAY 11, 2023

The guidance provides information to biopharma manufacturers regarding ophthalmic drugs packaged with eye cups, eye droppers, or other ophthalmic dispensers, where those articles meet the device definition. Case 3: Pre-Approval Product 1 The marketing application for Product 1 was submitted before issuance of the new guidance.

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Agency IQ

JULY 8, 2024

It also proposed several packaging changes to safeguard against misidentification. Medical gases were one of several topics during the deliberations that led up to the passage of the final legislative package, which was known as the Food and Drug Administration Safety and Innovation Act (or FDASIA).

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Agency IQ

AUGUST 2, 2024

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed.

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Agency IQ

MARCH 7, 2024

The “Collaboration” session, the subject of this article, encompassed three smaller segments – two shorter one-on-one interviews, and a one-hour panel discussion with representatives from EU government, trade associations, and the non-profit sector. see AgencyIQ’s article here for background on 1S1A.] “If

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Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI).

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Agency IQ

MAY 31, 2024

BY LAURA DIANGELO, MPH | MAY 29, 2024 10:52 PM CDT Quick background: The Guardant SHIELD test The Guardant Shield Blood Collection Kit is being considered under a Pre-Market Approval (PMA) application. The Shield blood test is an in vitro diagnostic (IVD) product intended to screen for colorectal cancer (CRC) markers in blood.

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