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.

Regulations 40

Regulations Animal Testing Production Marketing 40

Agency IQ

JUNE 17, 2024

BY SCOTT STEPHENS, MPA | JUN 10, 2024 10:26 PM CDT Switzerland and the EU’s impact on Swiss chemical regulations Though located in the heart of Europe, Switzerland is not a member of the European Union , nor of the European Economic Area (EEA). The adaptations to Annexes 2 and 3 of ChemV are expected to enter into force on September 1, 2024.

Regulations 40

Regulations Production International Packaging 40

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. Read AgencyIQ’s analysis of those exemptions here.

Trials 40

Trials Marketing Clinical Trials Regulations 40

Agency IQ

MARCH 7, 2024

FDA updates list of chemicals in the food supply under agency review The FDA has announced an update to its List of Select Chemicals in the Food Supply Under FDA Review, which details the agency’s ongoing post-market assessments for chemicals in human food. This marks the first update to the list, which first debuted in July 2023.

FDA 40

FDA Regulations Packaging Marketing 40

FDA Law Blog: Biosimilars

JANUARY 11, 2024

The first commercial marketing of each, according to the biosimilar patent settlement agreement, was July 1, 2023, which would render the FIE expiration date July 1, 2024. Thus, 18 months from approval would result in expiration of FIE on April 15, 2023, and on September 18, 2023 respectively.

Biosimilars 59

Biosimilars FDA Production Packaging 59

Agency IQ

OCTOBER 27, 2023

policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024. policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024.

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

Perficient: Drug Development

SEPTEMBER 25, 2023

UPTIS is expected to be introduced on General Motors passenger vehicles as soon as 2024. Availability of these services will vary depending on the model year, vehicle, trim level, and sometimes selected option packages. As examples of this are the General Motors OnStar, NissanConnect, and Toyota Connected Services systems.

Packaging 52

Packaging Engineering Marketing 52

Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. An observatory will also be created that publicly compiles information on the properties, uses, and market presence of certain chemicals.

Packaging 40

Packaging Regulations Laboratories Animal Testing 40

Agency IQ

JANUARY 19, 2024

BY KIRSTEN MESSMER, PHD, RAC | JAN 17, 2024 9:16 PM CST Quick background: EMA annual new medicines reports At the beginning of each calendar year, the EMA publishes a New Medicines Highlights report, providing a high-level overview of new medicines reviewed by the EMA’s Committee for Medicinal Products of Human Use (CHMP).

Biosimilars 40

Biosimilars FDA Production Treatment 40

Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

NOVEMBER 3, 2023

Several pandemic-era mechanisms to monitor medicine supply and prevent shortages are still in effect Article 81(2) of Directive 2001/83/EC obligates marketing authorization holders to “ensure appropriate and continued supplies” of an authorized medicine. The provision aims to ensure patient access to medicines where they have been marketed.

Regulations 40

Regulations International Pharmaceuticals Production 40

Agency IQ

MAY 31, 2024

What we expect EU chemical regulators to do in June 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Another consultation is closing this month on a draft implementing regulation that is amending the label format for fluorinated greenhouse gases (F-gases) under the new F-gas Regulation (EU) 2024/573.

Regulations 40

Regulations Production International Government 40

Agency IQ

JUNE 28, 2024

BY WALKER LIVINGSTON, ESQ | JUN 25, 2024 9:26 PM CDT Background: PFAS Per- and polyfluoroalkyl substances (PFAS) are a large class of synthetic organic chemicals that have been used in a wide array of industrial, commercial, and consumer applications since the 1940’s. Case study: California In April 2024, California state Sen.

Production 40

Production Regulations Compliance Packaging 40

Agency IQ

JUNE 26, 2023

incentives for rare disease-focused drug development were first enacted in 1983 under the Orphan Drug Act, including market exclusivities (7 years of marketing exclusivity), waivers from certain user fees, and tax credits for certain development activities (currently worth 25% of development costs). In the U.S.,

FDA 40

FDA Disease Regulations Production 40

Agency IQ

MAY 3, 2024

What we expect EU chemical regulators to do in May 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Name CAS RN Hazard endpoint proposed for vertebrate testing Deadline 10 testing proposals for seven chemical entries, including for dibromomethane, diethyl succinate, and triisobutyl phosphate.

Regulations 40

Regulations Packaging Production International 40

Agency IQ

DECEMBER 15, 2023

The EPA orders prohibit the nine significant new use notices the company submitted in December 2022 and are effective February 28, 2024. In addition, fluorine gases are used on high density polyethylene (HDPE) plastic packaging to improve container stability. BY PATRICIA ISCARO, ESQ.,

Packaging 40

Packaging Regulations Government Production 40

Agency IQ

MARCH 29, 2024

What we expect the EPA to do in April 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

OCTOBER 6, 2023

EFPIA, an industry lobby group for European pharmaceutical firms, emphasizes that despite pharmaceutical products being exempt from the proposal, there are no exemptions for the chemical processes that create the manufacturing equipment and packaging that are used to place pharmaceuticals on the market.

Pharmaceuticals 40

Pharmaceuticals Regulations Production Packaging 40

Agency IQ

MARCH 1, 2024

What we expect EU regulators to do in March 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA is receiving comments until the end of March on one substance being considered for exemption. The European Green Deal sets out the ambition to reach zero pollution for a toxic-free environment.

Regulations 40

Regulations Production Packaging Science 40

Agency IQ

NOVEMBER 20, 2023

Sentinel Update: PDUFA projects, ARIA sufficiency and building out a method for causal inference FDA’s Sentinel Initiative, the post-market, real-world data surveillance system, is nearing the end of its current five-year strategic plan. The Sentinel Initiative was kicked off in 2008 under the FDA Amendments Act (FDAAA).

Science 40

Science FDA Regulations Research 40

Agency IQ

MARCH 7, 2024

BY SCOTT STEPHENS, MPA | MAR 7, 2024 8:21 AM CST The format: an emphasis on conversations ECHA’s one-day event , titled “Shaping Tomorrow,” was held at the agency’s headquarters in Helsinki, Finland and live-streamed on ECHA’s website. Among the topics: stakeholder cooperation in the context of the green and digital transition.

Regulations 40

Regulations International Government Compliance 40

Agency IQ

FEBRUARY 15, 2024

European Commission unveils proposed ban on bisphenol A in food packaging The European Commission has proposed a total ban on bisphenol A and related substances for use in food contact materials. BY SCOTT STEPHENS, MPA | FEB 12, 2024 10:42 PM CST Bisphenol A (CAS No. BPA has also been restricted under REACH’s Annex XVII.

Packaging 40

Packaging Regulations Compliance Production 40

Agency IQ

MAY 17, 2024

BY RACHEL COE, MSC | MAY 10, 2024 5:19 PM CDT Generic Drug User Fee Amendments (GDUFA) III The Generic Drug User Fee Agreement (GDUFA) was first passed in 2012 as part of the FDA Safety and Innovation Act (FDASIA) to bolster FDA’s resources for the review and approval of generic drugs. What to expect on the day of the meeting?

Science 40

Science FDA Production Drugs 40

Agency IQ

FEBRUARY 2, 2024

What we expect EU regulators to do in February 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. BY SCOTT STEPHENS, MPA | JAN 26, 2024 10:22 PM CST Highlights of upcoming chemical regulatory activities Consultations under the REACH and CLP regulations are coming to an end in February.

Regulations 40

Regulations Production Government Marketing 40

Drug Discovery World

SEPTEMBER 13, 2023

The latest investment package follows a strong 18 months for the company, which more than doubled revenues in 2022 and has already secured substantial contracts with major pharma and biopharmaceutical companies for 2023 and 2024.

Clinical Trials 130

Clinical Trials Trials Packaging Marketing 130

Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. Orphan designation in the E.U.

Marketing 40

Marketing Biosimilars Regulations Drugs 40

Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. Here, AgencyIQ analyzes the root causes of these delays, and whether a trend could emerge in the coming years.

FDA 40

FDA Drugs Production Licensing 40

Agency IQ

JANUARY 4, 2024

What we expect EU regulators to do in January 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. 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.

Regulations 40

Regulations Packaging Production Government 40

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.

FDA 40

FDA Packaging Production International 40

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.

Packaging 40

Packaging Licensing Licensing Regulations 40

Agency IQ

APRIL 12, 2024

BY RACHEL COE, MSC | APR 11, 2024 1:06 PM CDT Regulatory background: Product potency and assays As defined in statute , the FDA uses the term “potency” to refer to the “specific ability or capability” of a product to “effect a given result.” Should potency assurance plans be submitted? If so, how?

Production 40

Production FDA Therapies Biochemical Assays 40

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. Figure 1 shows the designations by year since 2017 and through June 4, 2024. DEKRA received the first IVDR designation in October 2019.

Regulations 40

Regulations Compliance Packaging Production 40

Agency IQ

JUNE 21, 2024

An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024. BY KIRSTEN MESSMER, PHD, RAC | JUN 20, 2024 11:49 PM CDT Regulatory background: Post-authorization lifecycle management Medicinal products may be authorized nationally in specific E.U. countries, in all E.U.

Regulations 40

Regulations Production Marketing Vaccine 40

The Pharma Data

NOVEMBER 2, 2020

In preparation of the proposal, market practice in the US for peer companies has shown that the percentage for allocation to employees already employed normally amount to 10 to 150 per cent of the yearly Base salary, whereby the proposal in US Co-worker LTIP 2020 is that the allocation is limited to 10 to 100 per cent of the yearly Base Salary.

Marketing 40

Marketing Regulations Packaging Pharmaceutical Companies 40

Agency IQ

NOVEMBER 27, 2023

The changes, which should take effect in mid-2024, should result in drug ads with fewer distracting elements and more emphasis on the major risks of the drug. In some cases, the groups requested ad-by-ad reviews, potentially via collaboration with independent market research organizations. Interestingly, Merck & Co.

FDA 40

FDA Science Drugs Regulations 40

Agency IQ

NOVEMBER 10, 2023

Cosmetics must also be in compliance with the Fair Packaging and Labeling Act ( FP&L Act ); however, only color additives require FDA approval before they may be used in cosmetics. MoCRA also requires all marketed cosmetic products to be listed with the FDA by December 29, 2023. less than $1 million.

Production 40

Production FDA Compliance Packaging 40

Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

FDA 40

FDA Production Regulations Vaccine 40