The Guideline on good pharmacovigilance practices (GVP) now comprisese several updates:

The Guideline on good pharmacovigilance practices (GVP) now comprisese several updates:

On 8 August 2016, draft revision 2 of Module VI on management and reporting of adverse reactions and draft revision 1 (major revision) of Module IX on signal management with its Addendum I (Methodological Aspects of Signal Detection from Spontaneous Reports of Suspected Adverse Reactions) were released for public consultation until 14 October 2016.

The draft documents contain the following updates and amendments, which are highlighted in the respective documents:

GVP Module VI: 

• Update on the electronic reporting modalities of ICSRs (Individual Case Safety Report) under the new ICH-E2B(R3) format;
• Update on ICSRs reporting, following-up, duplicate detection, data quality management, in line with the provisions in Art. 24 of Reg. (EC) No 726/2004, Art. 107 and 107a of Dir. 2001/83/EC;
• Update on the validation of ICSRs based on patients and reporters identifiability;
• Update on the management of ICSRs described in the scientific literature;
• Update on the collection of information on patient’s age;
• Guidance on the management of suspected adverse reactions reported through medical enquiry and product information services;
• Guidance on the management of reports from post-authorisation efficacy studies;
• Transfer of the guidance on Emerging Safety Issue to GVP Module IX;
• Editorial amendments to align the format with other GVP Modules.

GVP Module IX with its new Addendum I:

• Revised definition and process for emerging safety issues, previously addressed in GVP Module VI (IX.C.3.1.);
• Streamlined information on scientific aspects of signal management (IX.B.2. to 4.), statistical aspects now addressed in Addendum I;
• Clarifications on terminology (IX.A.1.), roles and responsibilities (IX.C.1.) and processes (IX. Appendix 1);
• Criteria for access by marketing authorisation holders to case narratives held in EudraVigilance, with reference to Revision 2 of the EudraVigilance Access Policy (IX.C.2.1.);
• Updated guidance on the periodicity of monitoring of EudraVigilance data (IX.C.2.2.);
• Procedural options for signals validated by marketing authorisation holders (IX.C.3.).

On the following questions the agency seeks specific feedback:

• Are the proposed criteria for access to case narratives held in EudraVigilance by marketing authorisation holders acceptable (see IX.C.2.1.)?
•  Are the recommendations regarding the frequency of monitoring of EudraVigilance data acceptable (see IX.C.2.2.)?
• Are the proposed timelines and modalities for communication of emerging safety issues and validated signals by marketing authorisation holders clear and acceptable (see IX.C.3.)?

Additionally, the Product- or Population-Specific Considerations P.II on biological medicinal products were published as final on 15 August 2016, having been amended in the light of their public consultations.

Furtheremore, Module VIII – Post-authorisation safety studies (Rev 2) and Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev 2) were published as final on 8 August 2016.

For more Information please visit the EudraLex - Volume 9 

Pharmacovigilance Guidelines website

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FDA´s New Regulations for Drug Manufacturers

FDA´s New Regulations for Drug Manufacturers

The US Food and Drug Administration (FDA) amends its requirements for foreign and domestic establishment registration and listing for human drugs, including drugs that are regulated under a biologics license application, and animal drugs.

The final rule revises FDA's longstanding regulations governing drug establishment registration and drug listing. The amendments are aimed at modernizing these regulations and improving efficiency and reliability for both - FDA and drug manufacturers.

The more than two hundred pages final rule is expected to come into effect 90 days after publication in the Federal Register (scheduled August 31, 2016).

Up to now drug manufacturers have been required to register their establishments with FDA annually. Among other things, drug establishment registration identifies establishments for inspection by FDA. Furthermore, for each registered establishment it is required to submit a list of drugs it manufactures. The amendments adopted by this final rule modernize those regulations and bring them into conformance with recent amendments of the FD&C Act.

The FDA states that "the amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process."

In summary, the final rule requires electronic submission, unless waived in certain circumstances, of drug establishment registration and listing information. The electronic submission requirement is consistent with FDAAA (Food and Drug Administration Amendments Act) and with current practice. Thus, the final rule clarifies and completes the modernization of FDA´s electronic registration and listing systems.

Establishment registration and listing obligation rests with persons who manufacture, repack, relabel, or salvage drug products. The rule does not require persons who act only as private label distributors of drug products to register establishments or list drugs, but allows them to submit drug listing information as agents acting on behalf of persons who manufacture, repack, relabel, or salvage drug products. Also revised is the statute to specifiy that registrants must review and update registration information between 1 October and 31 December each year.

The revisons make several adjustments to the timing and substance of the submission of information to register a drug establishment and list drugs manufactured, repacked, relabeled, or salvaged at the establishment. Additionally the provisions governing FDA disclosure of drug registration and listing information, stating that with certain exceptions, establishment registration and drug listing information is generally available for public disclosure, have been updated.

For more information please see the final rule Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs.

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News about GMP/cGMP

The European Commission has published a revised Version 7 of its Question and Answers Document that sets out frequently asked questions on importation of active substances for medicinal products for human use. This document is continuously updated and further supplemented.

With this new version, Q&A 35 was added to clarify the requirements in case of importation of active substances released for sale before the expiration date of their written confirmation but only imported into the EU once the written confirmation had been expired. The detailed answer can be summarized to the extent that

“It is legitimate to consider that the guarantees of equivalence provided by the written confirmation apply to any API batch in the scope of the written confirmation which was released for sale within the period of validity of the written confirmation, even if not exported in that time period.”

This is acceptable provided that the data unequivocally proves the whole process and that a solid justification of why a valid written confirmation is not available is given. Furthermore, a minor editing of Q&A 10A and 29A was carried out and Q&A 29B was deleted.

Source:

EC: Medicinal Products for Human Use

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These are the four most common personality types – which are you? 

No two humans are exactly alike but researchers believe there are just a few main personality types most of us can be classified into.

A study on human behaviour has revealed that 90 per cent of us can be classified into just four basic personality types.

The different personality types, according to the research led by the Universidad Carlos III de Madrid (UC3M), are defined as: Optimistic, Pessimistic, Trusting and Envious.

Envious, is the most common, with 30 per cent compared to 20 per cent for each of the other groups, the study recently published in the journal Science Advances reveals.

The study analysed the responses of 541 volunteers to hundreds of social dilemmas, with options leading to collaboration or conflict with others.

Researchers used the data to develop a computer algorithm which set out to classify people according to their behaviour.

Here’s what they found:

Envious

Those who don’t actually mind what they achieve, as long as they’re better than everyone else.

Optimists

Those who believe that they and their partner will make the best choice for both of them.

Pessimists

Those who select the option which they see as the lesser of two evils.

Trusting group

Those who are born collaborators and who will always co-operate. They don’t really mind if they win or lose.

Anxo Sánchez explained in more detail: “Two people can hunt deer together, but if they are alone, they can only hunt rabbits.

“The person belonging to the Envious group will choose to hunt rabbits because he or she will be at least equal to the other hunter, or maybe even better; the Optimist will choose to hunt deer because that is the best option for both hunters; the Pessimist will go for rabbits because that way he or she is sure to catch something; and the hunter who belongs to the Trusting group will cooperate and choose to hunt deer, without a second thought.”

The researchers added there is a fifth, undefined group, representing 10 per cent of people, which the algorithm is unable to classify.

Meanwhile, here’s why beautiful people ‘are seen as more intelligent’.

Another study claims intelligent people are more easily distracted at work.

Revealed: The age adults are at their ‘healthiest and happiest’.

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FDA Issues Guidance on the Use of Plasma Fibrinogen Biomarker

The agency provides a qualified context of use for the biomarker plasma fibrinogen.

On Sept. 14, 2016, FDA published guidance providing a qualified context of use (COU) for plasma fibrinogen, a biomarker, in interventional clinical trials of patients with chronic obstructive pulmonary disease (COPD) at high risk for exacerbations and/or all-cause mortality. According to FDA, “fibrinogen is an acute phase protein that is elevated in inflammation. It is a soluble plasma glycoprotein that is converted by thrombin to fibrin during blood clot formation.”

The experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research’s (CDER) Biomarker Qualification Program are also described. The guidance states that drug developers may use plasma fibrinogen “for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker.” FDA states that the use of the biomarker outside of the qualified COU will be considered on a case-by-case basis and more information regarding the expanded use may be required.

Source: Download  FDA

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Woman dies of dengue in Mumbai;122 cases reported this monsoon

A woman has succumbed to dengue in the city this monsoon even as 122 cases of the vector disease have been reported here during this rainy season, officials said. 

Besides, over 1,500 people have been admitted to various hospitals in the city for suspected dengue this month alone, according to figures of the Mumbai civic body.

"A woman, who came from outside and was staying in Vikhroli, was infected by dengue and she lost her life in the civic hospital on September 8," an official said today. 

"The death of a suburban Borivali resident has also been reported at a private hospital on September 13 this month, that we need to cross-check and confirm whether it is due to dengue only," she said. 

The civic administration has taken cognisance of Dengue and the insecticide department of the Brihanmumbai Municipal Corporation (BMC) was doing every bit to prevent it, the official further said. 

BMC's executive health officer Dr Padmaja Keskar appealed to the citizens to identify and destroy the mosquito-breeding spots to prevent the disease. 

"We appeal to the people of the city and request them to exercise utmost caution and destroy mosquito breeding spots in and around their houses or housing societies," she said. 

Meanwhile, around 4-6 cops from suburban Jogeshwari police station are also reported to be suffering from dengue, a policeman said. 

When asked about the policemen's dengue case, Keskar said, "We too have got the same report. Our team visited and found breeding spots for the Aedes mosquito, which is the carrier of the dengue virus." 

"But the policemen are down with dengue can be said only after proper test is conducted on them," she said. 

Currently, 122 cases of dengue have been reported and patients are being treated in various government and private hospitals across the city, she said. 

According the civic statistics, over 1,500 people have been admitted to various hospitals in the city due to suspected dengue since the beginning of this month. 

With city and other parts of the state receiving intermittent rainfall over the past few months, there has been a rise in mosquito-borne diseases like dengue and malaria. 

Mosquito-breeding proliferations are most common during the months of August and September due to many spots of stagnant rain water.

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