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11
August
2022
GAMP®5, a Risk-Based Approach to Compliant GxP Computerized Systems Guidelines, is a globally accepted standard for the validation of computerised systems that has been recently revised. In the end of July 2002, a new 2nd edition has been published.
09
August
2022
European Commission published the Implementing Regulation (EU) 2022/1107 to establish common specifications for certain class D in vitro diagnostic medical devices (IVD’s) considered to be high-risk.
09
August
2022
U.S. Food and Drug Administration Agency (US FDA) is announcing the availability of a draft guidance for industry titled Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.
05
August
2022
The European Medicines Agency (EMA) will be updating its Guideline on active substances to incorporate strategies for controlling and preventing nitrosamines in drug products and active pharmaceutical ingredients
01
August
2022
Compressed gases are used in a lot of different steps during pharmaceutical manufacturing
29
July
2022
The definition of whistleblowing as per the Collins English dictionary is the act of telling the authorities or the public that the organization you are working for is doing something immoral or illegal.”
27
July
2022
As part of US FDA’s continued efforts to improve transparency and provide helpful information to regulated industry and the public, the agency is issuing two final guidances for generic drug applicants.
22
July
2022
The U.S. Food & Drug Administration (FDA) posted an article on the ways the FDA is regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food, and cosmetics (Is it Really “FDA Approved”).
21
July
2022
USP Headquarters recently published the intend to revise the Description and relative solubility of USP and NF Articles reference table.
14
July
2022
Proposed changes of biocidal products should be classified in different categories
13
July
2022
The current Q3D(R2) Guideline reached Step 4 on 26th of April 2022, and included a correction of PDE’s for gold, silver and nickel, Gold and Silver monographs and an addition of limits for elemental impurities by the cutaneous and transcutaneous route.
04
July
2022
Commission Regulation (EU) 2022/63 of 14 January 2022 amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the food additive titanium dioxide (the Regulation) entered into force following its publication in the Official Journal of the European Union on 18th January 2022.
01
July
2022
On June 27th 2022 European Medicines Agency (EMA) published revised IRIS guide for applicants (EMA/444925/2018)
29
June
2022
U.S. Food and Drug Administration Agency (US FDA) is announcing the availability of a draft guidance for industry
28
June
2022
US Food and Drug Administration Agency (US FDA) has announced the availability of a proposed rule National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs).
23
June
2022
With many years of experience in GMP projects, Billev Pharma East experts can accurately identify defects and deviations in GMP systems
22
June
2022
The European Commission has revised certain information requirements for registering chemicals.
21
June
2022
Billev Pharma East can conduct on-site supplier audits on your behalf to ensure that their manufacturing activities are being executed according to your specifications and the applicable regulations.
20
June
2022
In the annual report 2021 EMA summarized activities, achievements, and future plans.
16
June
2022
With the application of the EU Clinical Trials Regulation No 536/2014 (CTR) some labelling requirements for investigational medicinal products (IMP’s) have changed.
15
June
2022
The new Annex 21 Importation of medicinal products to the EU Good Manufacturing Practice (GMP) guidelines that has been published on February 21st, 2022, will enter into force on August 21st 2022.
14
June
2022
EFSA is holding an info-session, open to applicants and other groups or individuals with an interest in this issue and novel food more generally.
09
June
2022
On 7 June 2022, EMA’s Medicines Shortages Steering Group (MSSG) adopted the list of PDF icon critical medicines for the COVID-19 public health emergency .
08
June
2022
The consequence of the new Medical Device Regulation (EU) 2017/745 was update of CMDh Question & Answer document for Variations in May 2022.
06
June
2022
On 4th of May 2022, the Federal Council adopted the new Ordinance on In vitro Diagnostic Medical Devices (IvDO) and the amendment to the Ordinance on Clinical Trials with Medical Devices (CTO-MedD).
03
June
2022
The template can be used immediately but will become mandatory for new DCP MA applications submitted as of 1 July 2022.
02
June
2022
For many medicinal products, storage and transportation temperatures are a highly significant factor in maintaining the quality of medicinal products throughout the distribution network.
01
June
2022
With describing the special problems of HMPs and the differences to medicinal products containing chemically defined active substances.
30
May
2022
Theranostics are diagnostic procedures, used to select appropriate patients for the appropriate therapy, maximizing the success rate and minimizing the adverse reactions.
30
May
2022
Outsourcing is a critical process in the pharmaceutical industry.
27
May
2022
Transition period for the use of the In Vitro Diagnostic Regulation 2017/746 (IVDR) came to an end, hence as of 26th of May its provisions are mandatory to be followed by all in vitro diagnostic medical device sector.
26
May
2022
Five out of seven of these Annexes now correspond to the most recent status in accordance with the new requirements of the Clinical Trial Regulations No 536/2014 (CRT).
25
May
2022
ICH Harmonised Guideline for elemental impurities Q3D (R2) was adopted on 26th of April 2022.
19
May
2022
The PMDA thereby clarifies its intention to promote global clinical trials in which Japan is involved.
18
May
2022
Parallel distribution is defined as the distribution of a centrally authorised medicinal product from one Member State to another by a pharmaceutical company independent of the marketing authorisation holder.
17
May
2022
This ATP brings changes to the labelling and classification of some existing harmonized substances and adds new harmonized substances in Part 3 of Annex VI.
17
May
2022
The purpose of this consultation is to collect relevant information from stakeholders to help the GMP/GDP Inspectors Working Group to finalise this Question and Answers guidance on remote batch certification / confirmation by the QP on a routine basis.
12
May
2022
The annual report is set out in line with the format and objectives of the 2021 – 2023 three-year work plan and gives among other topics a detailed update on all existing MRAs
11
May
2022
Interesting article about future Pharmacovigilance.
09
May
2022
Spreadsheets need to comply with several requirements, however controls are quite often inadequate, and this may result in a compliance risk.
05
May
2022
The document describes principles and examples of tools for quality risk management and consists of 56 pages of comments from organizations such as the PDA, EFPIA and many others.
04
May
2022
EU Commission proposal to address outstanding supply of medicines to markets that have been historically supplied through or by Great Britain
03
May
2022
The US FDA presented revised plan for collecting quality metrics from drug manufacturers end of March 2022.
02
May
2022
European Commission launches the public consultation on the revision of the Cosmetics Regulation.
28
April
2022
Companies should have written procedures to ensure that sewage and refuse are properly removed and disposed of.
27
April
2022
Total organic carbon test (TOC) to replace test for oxidisable substances in sterile water for injection?
26
April
2022
Expectations for bootstrapping to calculate the 90% confidence interval for the f2 similarity factor when comparing dissolution profiles with high variability.
25
April
2022
22
April
2022
Applicant’s response template and RMS Validation Checklist in DCP were updated.
20
April
2022
ICH Harmonized Guidelines Q14 and Q2(R2) (Analytical procedure development – Validation of analytical procedures) published for consultation.
19
April
2022
The review of batch (manufacturing) records creates a story of the materials, manufacturing, and packaging involved in the production of medicinal products.
14
April
2022
On 11th of April 2022, World Health Organization (WHO) published a practical guide How to temperature map cold chain equipment and storage areas.
13
April
2022
The Australian regulatory authority for therapeutic goods TGA has updated its Guidance on quality requirements for medicinal cannabis products.
12
April
2022
The Medical Device Coordination Group (MDCG), a group of Member States experts, endorsed a joint implementation plan on the implementation of the IVDR.
04
April
2022
Slovenian notified body SIQ successfully passed the designation and notification procedure under the Regulation (EU) 2017/745 on Medical Devices (MDR).
01
April
2022
France is moving forward regarding medical cannabis cultivation and production.
30
March
2022
Combination products became an essential tool for the delivery of medicinal products and in the last years the number of marketing authorisation for these types of devices increased significantly.
30
March
2022
European Commission (EC) is reporting progress in implementing strategic approach to pharmaceuticals in the environment. This approach involves all phases of lifecycle of pharmaceuticals, from development, manufacture, use and disposal.
29
March
2022
A regulation strengthening the role of the EMA in crisis preparedness and management for medicinal products and medical devices has been published in the Official Journal of the EU (Regulation (EU) 2022/123).
28
March
2022
A risk-based approach is essential for creating a practical supply chain security standard for all supply chain partners.
25
March
2022
EDQM updates application forms for Certificate of Suitability (CEP) applications.
24
March
2022
Guidelines on Good Distribution Practice (GDP) of medicinal products define the need for a self-inspection programme.
24
March
2022
US FDA will host a free virtual public workshop on May 9 – 10, 2022 on Generic Drug Science and Research Initiatives.
23
March
2022
EMA initiated the establishment of the Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU®).
23
March
2022
EU GMP Annex 1 Manufacture of sterile medicinal products revision to be released mid-year
22
March
2022
The agreement between Switzerland and the European Union EU) on mutual recognition in relation to conformity assessment (MRA) of medical devices that aimed to facilitate the trade ended in May 2021.
22
March
2022
EMA will organise an online walk-in clinic on CTIS on 28.3.2022, 16:00-17:00 CEST
21
March
2022
EMA updates guidance in forms of questions and answers (Q&A) on Good manufacturing practice / Good distribution practice and Good Clinical practise
21
March
2022
Environment and sustainability questions are becoming common for all industry sectors, thus healthcare sector is no exemption.
17
March
2022
The new data raised concerns from a toxicological point of view.
17
March
2022
Due to the Brexit, the EU Clinical Trial Regulation is not (directly) applicable in UK.
16
March
2022
Revised guidance relating to Clinical Trials during the COVID-19 Pandemic.
15
March
2022
Rules for electronic instructions for use for medical devices.
14
March
2022
New EU rules for safe and high-quality medicines for animals.
11
March
2022
IPEC’s position on the role of excipients when conducting nitrosamine risk assessments for drug products.
10
March
2022
Concept Paper on the revision of guideline on Good agricultural and collection practice (GACP) for starting materials of herbal origin published
07
March
2022
PIC/S has updated its GMP guide, aligning it with EU requirements to promote harmonization.
05
March
2022
What is foreseen for medicines containing Titanium dioxide (E171)?
04
March
2022
US FDA formally proposes aligning Quality System Regulations with ISO 13485 – another step forward to better international harmonization.
03
March
2022
EMA Guidelines on the requirements for quality documentation concerning medicinal products in clinical trials.
01
March
2022
Currently in the EU only national pharmacopoeia monographs are available for Cannabis Flower and Cannabis Extracts.
28
February
2022
On February 21st, EMA published a long-awaited Annex 21 to the EU-GMP Guidelines (“Importation of medicinal products”).
13
February
2022
On Monday 31st January 2022 at 9:00 a.m. CET, the Clinical Trials Information System (CTIS) has gone live.
18
August
2021
Schedule a meeting with Alenka.
26
May
2021

MDR

Medical Device Regulation comes into application on 26th of May 2021.
06
May
2021
Will EFSA assessment impact medicinal products? EMA quality working group is organizing a meeting with industry on 10 June.
18
September
2020
Contact us if you need to be assured that your translations intended for healthcare professionals and patients are prepared by experts understanding the implications behind and medical language
12
June
2020
BILLEV PHARMA EAST can deliver an export report on ERA with strategy for development of ERA, required calculations and justifications in accordance with the guidelines.
22
April
2020
We are proud to announce the availability of our GCP auditor, experienced and trained to perform independent audits and deliver audit report.
09
March
2020
Medical device manufacturers should be aware of obligations laid down in Article 15 of the MDR where there is requirement for person responsible for regulatory compliance (PRRC) which also checks conf…
10
January
2020
Billev Pharma East is looking forward to attending the upcoming 13th Pharmacovigilance Conference in Amsterdam.
09
January
2020
Risk evaluations that have been required for EU medicinal products, after potentially carcinogenic nitrosamines were identified in some classes of medicines, are still ongoing.
23
July
2019
Transitional period for the new EU legislation on Medical Devices that entered into force in May 2017 is getting close to an end.
29
March
2019
Billev Pharma East is aware that finding a suitable QP represents a huge challenge for many pharmaceutical companies and has the expertise to help you.
24
February
2019
There are still so many uncertainties concerning Brexit, however, the currently planned date of UK withdrawal (‘hard Brexit scenario’) is approaching at a high speed…
13
February
2019
In January we attended the 12th Pharmacovigilance Conference and 18th Regulatory and Scientific Affairs Conference
06
February
2018
New versions of electronic Applications Forms for marketing authorisation applications, renewals and variations for human and veterinary medicines have been released.