Agency IQ

AUGUST 9, 2024

Commission proposes exemptions to UV-328 ban under POPs Regulation The European Commission plans to implement exemptions introduced under the Stockholm Convention’s 2023 ban of UV-328, an ultraviolet-light absorbing persistent organic pollutant (POP). This exemption is in accordance with Article 4(1)b of the POPs Regulation.

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.

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Clinical Trials Regulations Trials Pharmaceutical Companies 52

Drug Discovery World

JULY 18, 2024

The therapy is a humanized monoclonal antibody engineered to neutralise the tumour-produced Growth Differentiation Factor-15 (GDF-15), which acts as a key regulator of immune resistance to cancer therapies. Visugromab has already demonstrated positive anti-tumour activity in combination with checkpoint inhibitor treatment.

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thought leadership

MAY 7, 2024

Are You Ready for Mandatory EU Health Technology Assessment Regulation (HTAR) Implementation Beginning January 2025? Pharmaceutical companies need to be prepared for the new European Health Technology Assessment Regulation (HTAR), which will take effect in January 2025.

Pharmaceutical Companies 59

Pharmaceutical Companies International Regulations Pharmaceuticals 59

Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 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.

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Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 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.

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Agency IQ

NOVEMBER 10, 2023

The still-pending agreement seems likely to soon be adopted, which would trigger an application date of January 1, 2025. The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers.

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Regulations Pharmaceuticals Government Therapies 40

Drug Discovery World

AUGUST 22, 2024

We aim to initiate the first human clinical studies in our lead indications in 2025, representing monumental progress for the cellular rejuvenation field.” She says that overcoming these challenges requires collaborative efforts from industry stakeholders, regulators, and healthcare providers to speed up the process.

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BioPharma Drive: Drug Pricing

DECEMBER 19, 2023

A decision by European regulators to revoke approvals for five generic versions of Biogen's multiple sclerosis medicine helps cement the drug's monopoly there through early 2025.

Marketing 67

Marketing Regulations Drugs 67

Agency IQ

MAY 17, 2024

The bill will set a variety of timelines for state regulators to identify industrial uses of PFAS and develop action levels for PFAS in state waters by mid-2025. BY WALKER LIVINGSTON, ESQ On May 9, 2024, Maryland Governor WES MOORE approved the Protecting State Waters From PFAS Pollution Act.

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Regulations 59

thought leadership

JUNE 4, 2024

Health technology developers (HTD) planning submission of a centralized Market Authorization Application (MAA) to the European Medicines Agency (EMA) should being preparing today for the implementation of the European Health Technology Assessment Regulation (HTAR).

Therapies 59

Therapies Regulations Production Marketing 59

Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 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.

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Regulations Production Biosimilars Clinical Trials 40

Agency IQ

APRIL 12, 2024

EPA releases final PFAS drinking water regulations – with five-year compliance timeline The EPA has released its much-awaited National Primary Drinking Water Regulation for six different PFAS. Part 141 and contains the implementing regulations from the act. The SDWA is administered by the EPA at 40 C.F.R.

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Compliance Regulations Treatment Production 40

Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new 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.

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

Agency IQ

JULY 21, 2023

New EPA regulations to sweep up lead levels in many structures The Environmental Protection Agency has announced new dust-lead hazard standards and clearance levels, which regulate levels of lead dust on floors and windowsills. New proposed EPA regulations On July 12, 2023, the EPA announced that it was reducing both the DLHS and DLCL.

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Regulations Compliance Laboratories 40

Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new 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.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

MARCH 25, 2024

The Community Rolling Action Plan (CoRAP) belongs to the “E” in REACH (registration, evaluation, authorization, and restriction of chemicals; Regulation (EC) 1907/2006 ). ECHA publishes the 2024 update to CoRAP On March 19, ECHA published the list of CoRAP substances to be evaluated during 2024, 2025 and 2026.

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Compliance Production Regulations 40

Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

Regulations 40

Regulations Animal Testing Production Marketing 40

FDA Law Blog: Biosimilars

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

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Production Compliance Regulations FDA 64

FDA Law Blog: Biosimilars

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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Compliance Laboratories FDA Regulations 64

Agency IQ

FEBRUARY 15, 2024

MHRA selects eight technologies to help it test its new innovative devices pathway The British regulator and its partners just released the list of products and companies chosen to participate in the pilot of its Innovative Device Access Pathway (IDAP). device regulations and the pilot for innovative products. Life Sciences Vision.

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Regulations Production Science Vaccine 40

Agency IQ

JULY 26, 2024

EU executive consults on proposed update to PIC chemical lists Regulation (EU) 649/2012 (PIC Regulation) is the main act on the export and import of hazardous chemicals between the European Union and third countries. Part 1 of the annex lists substances that carry the obligation to submit an export notification.

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Agency IQ

MARCH 25, 2024

AgencyIQ Guidance Tracker: European medical device and diagnostics guidance documents With the many moving parts of the European medical device and IVD regulations, it can be difficult to keep up on planned guidance and other publications, published documents and document revisions. Our new resource aims to help make this a little bit easier.

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Drug Discovery World

AUGUST 14, 2023

billion in 2025 at a rate of 28.7% Preparing early and understanding those differences – while also working with regulators toward common ground approaches – will be key to successfully navigating the approval process, ultimately bringing CGTs to patients who need them, more quickly. billion in 2020 to $15.5

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Agency IQ

JULY 22, 2024

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

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Animal Testing Regulations Production Compliance 40

Agency IQ

FEBRUARY 23, 2024

Background: PFAS regulation in California PFAS have been the subject of significant regulations in California, beginning in the 2010s [for an in-depth review of PFAS regulation in California, see the AgencyIQ analysis here ]. In 2019, the state began to significantly ramp up its PFAS regulation and research.

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The Pharma Data

SEPTEMBER 16, 2020

SLB linked to 2025 Patient Access Targets to increase patients reached in low- and middle-income countries (LMICs) with strategic innovative therapies by 200% and the Novartis Flagship Programs by 50%. Novartis is taking bold steps to increase patient reach in LMICs with its strategic innovative therapies by at least 200% by 2025.

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Regulations Therapies Government Disease 52

Agency IQ

JULY 7, 2023

building off the EMA’s Strategy through 2025. regulators have previously discussed , using RWE “for regulatory decision-making is already a reality, and there is increasing interest in using big data and advanced analytics as a complementary source of evidence.” What is real-world data (RWD) and evidence (RWE)?

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Regulations Research Production Government 40

Agency IQ

JUNE 28, 2024

Generally, how have states attempted to regulate PFAS? States are attempting to regulate PFAS in a variety of ways, including via multiple in-state regulatory and legislative avenues. Most notably, the bill pushes the time for compliance with the 2021 statute from January 1, 2023, to January 1, 2025.

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The Pharma Data

NOVEMBER 4, 2020

5, 2020 /PRNewswire/ — Bactiguard presents updated financial targets for 2025 in connection with the company’s financial report for the third quarter of 2020. Updated long-term financial targets for the period up to 2025: Growth. EBITDA margin of at least 30 percent at the end of the five-year period 2025 (unchanged).

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Licensing Licensing Production Marketing 52

Agency IQ

AUGUST 4, 2023

Animal testing has been banned for cosmetic products since 2013 under the EU Cosmetics Regulation. Regulations are legislative instruments that apply across all member states as written. The regulation also obliges sharing information on already registered chemicals and, whenever possible, reducing unnecessary duplication of testing.

Animal Testing 40

Animal Testing Regulations Production Research 40

Agency IQ

MAY 10, 2024

The proposal for a regulation on the sustainable use of pesticides (SUR), however, died in European Parliament in November 2023. Again, it emphasized a goal of reducing pesticide use by half, this time by 2025. The newest iteration of Ecophyto again seeks to cut pesticide use in half, though this time by 2030 rather than 2025.

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Agency IQ

MAY 31, 2024

What we expect the EPA to do in June 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. This is what OIRA is currently reviewing.

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Agency IQ

MAY 3, 2024

What we expect the EPA to do in May 2024 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. TSCA new chemicals procedural regulations. TSCA risk management rules.

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Regulations Government Engineering International 40

The Premier Consulting Blog

DECEMBER 14, 2022

By 2025, funding for DTx is expected to reach $56 billion. DTx require both clinical evidence and real-world outcomes and must be cleared or certified by regulators to support claims of intended use, risk, and efficacy.

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Production Regulations Pharmaceuticals Therapies 52

The Pharma Data

FEBRUARY 22, 2021

By 2025, the company aspires to establish a 50/50 gender balance as an average across all combined management levels including lower and middle management (currently 40 percent women and 60 percent men). Bayer is further strengthening its efforts to foster a more inclusive and diverse workforce and culture.

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The Pharma Data

FEBRUARY 22, 2021

By 2025, the company aspires to establish a 50/50 gender balance as an average across all combined management levels including lower and middle management (currently 40 percent women and 60 percent men). Bayer is further strengthening its efforts to foster a more inclusive and diverse workforce and culture.

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