Drug Patent Watch

FEBRUARY 26, 2025

In this article, we'll delve into the world of drafting drug patent applications for biologic drugs. However, the patentability of biologics is governed by specific laws and regulations, such as the Biologics Price Competition and Innovation Act (BPCIA). Read the full article here: [link]

Drugs 59

Drugs Government Regulations Compliance 59

Agency IQ

MAY 28, 2024

BY COREY JASEPH, MS, RAC The British medical device regulator just issued its promised framework on international recognition. Fill out the form to read the full article.

International 52

International Regulations Marketing 52

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. Regulatory background Biocides are regulated primarily by the Biocidal Products Regulation (BPR) (528/2012/EU).

Regulations 59

Regulations Production Marketing 59

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). UV-328 is used in a wide range of applications as a UV absorber and stabilizer.

Regulations 40

Regulations Production International Marketing 40

Agency IQ

JUNE 17, 2024

Swiss regulators align with EU on chemicals, biocides The Swiss Notification Authority for Chemicals has announced new adaptations are in the offing that will harmonize parts of the Swiss Chemicals and Biocidal Products ordinances with recent updates to corresponding EU legislation. the authorization list).

Regulations 40

Regulations Production International Packaging 40

Drug Target Review

DECEMBER 20, 2024

These innovations have started to shift industry perceptions, positioning AI as a transformative tool that could alter how drugs are developed, tested, and brought to market. Regulators care a lot about controlling the Type 1 error rate of the clinical trial, Smith notes.

Clinical Trials 128

Clinical Trials Trials Pharmaceuticals Drug Development 128

Perficient: Drug Development

AUGUST 19, 2024

I have even heard the phrase “Please check the report, I don’t understand the models and hence trust the number” So, in the risk function, while this is a race for data aggregation, structured data, unstructured data, data quality, data granularity, news feeds, market overviews, its also a challenge from an acceptance perspective.

Regulations 109

Regulations Marketing Government Compliance 109

Agency IQ

JUNE 21, 2024

Commission proposes guidelines to flesh out the newly finalized Variations Regulation This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024.

Regulations 40

Regulations Marketing Production Vaccine 40

Agency IQ

JANUARY 4, 2024

The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. Fill out the form to read the full article. AgencyIQ takes a look at what this could mean for medical device manufacturers.

Marketing 59

Marketing Regulations Production 59

Tecan

MAY 3, 2022

By Günter Weisshaar The announcement of the In Vitro Diagnostics Regulation (IVDR) in 2017 was celebrated as an essential upgrade to in vitro diagnostic (IVD) device regulations in Europe. The IVDR is the European Union’s regulatory overhaul of pre- and post-market requirements for IVD devices.

Regulations 52

Regulations Production Marketing Compliance 52

Agency IQ

MARCH 7, 2024

British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. post-market regulation here.]

Regulations 40

Regulations International Production Government 40

Agency IQ

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

International 40

International Regulations Licensing Licensing 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

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. On May 29-30, the agency will host ECHA IT Days , a two-day conference held in Helsinki, Finland dedicated to all things related to information technology and chemical regulations.

Regulations 40

Regulations Packaging Production International 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

Agency IQ

DECEMBER 1, 2023

What we expect EU regulators to do in December 2023 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. For more background on the glyphosate authorization, see AgencyIQ’s October 12 article.] Events happening next month include two ECHA meetings (i.e.,

Regulations 40

Regulations Production International Marketing 40

PPD

MARCH 11, 2025

Challenge #4: Regulatory and market access hurdles The regulatory and health technology assessment (HTA) pathways for rare disease therapies are complex and vary by region. With the new EU HTA Regulation impacting orphan medicines, navigating these pathways has become even more challenging.

Drug Development 52

Drug Development Clinical Trials Disease Trials 52

Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. both pre- and post-market.

Regulations 40

Regulations Government Compliance International 40

Agency IQ

OCTOBER 27, 2023

What we expect EU regulators to do in November 2023 Welcome to AgencyIQ’s roundup of upcoming regulatory activities in the EU chemicals sector. Regulation on detergents and surfactants The expert working group on detergents is scheduled to hold a meeting on November 17.

Regulations 40

Regulations Production Packaging International 40

Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. Fill out the form to read the full article. from the E.U.

International 52

International Regulations Pharmaceuticals Production 52

Drug Target Review

APRIL 7, 2025

Involved in various physiological processes, such as vision, taste, smell, immune response and neurotransmission, GPCRs are activated by various molecules including hormones, neurotransmitters and environmental stimuli, which trigger a cascade of cellular events that help regulate bodily functions.

Fragment Screening 52

Fragment Screening Drugs Small Molecule Biophysical Assays 52

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 consultations under the CLP Regulation closing in March CLP: Harmonized classification and labeling (CLH) Consultations on classification and labeling harmonization (CLH) are open for 60 days.

Regulations 40

Regulations Production Packaging Science 40

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.

Regulations 40

Regulations Pharmaceuticals Production Vaccine 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. Safeners and synergists are subject to the same approval conditions that active substances are under the PPPR’s Articles 4 and 5-21 , pursuant to Article 25(1)-(2).

Regulations 40

Regulations Animal Testing Production Marketing 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. ECHA plays a central role in this reassignment of duties, and it would make sense for the basic regulation to be introduced at the same time as these other proposals.

Regulations 40

Regulations Packaging Production Government 40

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.

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. provides a 10-year market exclusivity period. Orphan designation in the E.U.

Marketing 40

Marketing Regulations Biosimilars Drugs 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.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

The Pharma Data

DECEMBER 10, 2020

The ADSs have been approved for listing on the Nasdaq Global Select Market and are expected to begin trading on December 11, 2020 under the ticker symbol “NBTX.” The Company’s ordinary shares are listed on the regulated market of Euronext Paris under the ticker symbol “NANO.”. Type of Offering.

Marketing 52

Marketing Regulations Treatment Clinical Trials 52

Agency IQ

JANUARY 4, 2024

Swissmedic reorg adds new focus on medical device market surveillance The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. in 2021, Switzerland became a third country from the E.U.

Marketing 40

Marketing Regulations Clinical Trials International 40

Drug Target Review

JULY 4, 2023

In this article, Petra Dieterich, Ian Glassford, and Jeff Mocny, Scientific Leaders at Abzena discuss real-world data that is challenging traditional scientific thinking on the ADC therapeutic window. The global ADC market is expected to continue this steep upward trajectory and is anticipated to exceed $16 Billion by 2026.

Small Molecule 145

Small Molecule Drugs Clinical Pharmacology Trials 145

Agency IQ

NOVEMBER 10, 2023

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. There are other fee-related regulations as well.

Regulations 40

Regulations Pharmaceuticals Government Therapies 40

Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 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.

Regulations 40

Regulations Clinical Trials Production Trials 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

Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. This article explores the likely impact of the AI Act on software and systems used in clinical research and how it affects entities outside the EU. These risks face fewer regulations but must meet certain standards to ensure ethical use.

Clinical Research 98

Clinical Research Research Clinical Trials Compliance 98

Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 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.

Regulations 40

Regulations Biosimilars Clinical Trials Production 40

Agency IQ

FEBRUARY 15, 2024

They vary from articles like reusable bottles and tableware, to waterpipes, sports equipment, flexible glass applications, CDs and DVDs, and many more. BPA has been identified as a substance of very high concern (SVHC) under REACH , satisfying the Article 57 criteria for reproductive toxicity (Art. eye damage, cat. eye damage, cat.

Packaging 40

Packaging Regulations Compliance Production 40