News

The Central Drugs Standard Control Organization (CDSCO) has issued a spurious drug alert for popular medications  - Alkem’s Taxim-O (Antibiotic Cefixime), Pan D (Pantoprazole + Domperidone for acidity and indigestion), and Sun Pharma’s Rosuvas 10 (Rosuvastatin for lowering cholesterol). Samples...

In September 2024, the European Commission (EC) revoked the Conditional Marketing Authorisation (CMA) for Advanz Pharma’s Ocaliva (obeticholic acid), a second-line treatment for patients with primary biliary cholangitis (PBC). But the General Court of the European Union temporarily suspended the...

New Delhi based Unexo Life Sciences has initiated a major recall of several medicated patch drug products in US following critical deviations flagged by USFDA in the manufacture of drug products. The recall include more than 12 Million patches of...

Aurobindo is recalling Cinacalcet tablets in US due to nitrosamine NDSRI impurity N-Nitroso-cinacalcet. Aurobindo has initiated recall of 17 batches of the drug product across different strengths 30 mg, 60 mg and 90 mg Cinacalcet tablets Earlier in October 2024,...

Chinese OTC Manufacturer Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd was inspected by USFDA in March 2024. During the inspection FDA observed significant GMP violations at the facility (FEI 3006283468). Manufacturing – Filling equipment were observed to be dirty and, in...

USFDA is proposing to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) drug products for nasal congestion. An review determined that oral phenylephrine is not effective for relief of nasal congestion. As this is a proposed order, companies may...

FDA has published the USFDA Form 483 issued to Novo Nordisk API manufacturing facility at Kalundborg, Denmark. The site (FEI 3002807751) which manufacture the block buster Semaglutide was inspected by USFDA investigators Lindsey Brown, Ralph M. Bernstein, Maxwell Korang-Yeboah, and...

The USFDA has published a new guidance titled "Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA," intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs). DMF holders can request an...

CDSCO has published list of sixtyseven Drugs & Medicinal products as Not of Standard Quality (NSQ) in September 2024. Central and State Drug authorities routinely pick samples of drug products from point of sale and distribution points and get the...

CDSCO has published list of drugs declared as spurious in the month of September 2024. The list includes popular medicines Deca-Durabolin 25 Injection (Zydus), Shelcal 500 (Torrent), Urimax D (Cipla), Pan D (Alkem). CDSCO routinely samples drugs and medicines from sales...

Accord Healthcare Inc, US is recalling one lot of Cisplatin injection due to failed impurities. The drug product is manufactured by Intas Pharmaceuticals at their Pharmez facility in Ahmedabad, India. The recall was initiated after batch P2202009 failed for unspecified...

USFDA has approved Inavolisib ((Itovebi) of Genentech in combination with palbociclib and fulvestrant, for the treatment of PIK3CA-mutated HR-positive HER2-negative breast cancer. As per Roche press release HR-positive breast cancer is the most prevalent type of all breast cancers, accounting...

The European Medicines Agency (EMA) has initiated a review of finasteride and dutasteride due to concerns about suicidal ideation (suicidal thoughts) and behaviors. In Europe, medicines containing finasteride and dutasteride are marketed under various trade names such as Propecia (Organon),...

CDSCO has published an update on the Spurious and Misbranded drugs in September 2024. Medicinal Products of Pharma Majors Sun Pharma (Pulmosil, Pantocid, Ursocol 300), Glenmark (Telma H) and Macleods (Defcort 6) which were found to be failing for different...

CDSCO has published alert of list of drugs Not of Standard Quality (NSQ) identified during Aug 2024. Fortyeight incidents of Not of Standard Quality drugs are reported by the Central Laboratories (Chandigarh, Kolkata and Guwahati) in August 2024. The list...

FDA has issued an Updated Guidance for Control of Nitrosamines in Human Drugs in September 2024. This guidance revises the final guidance of the same title issued on February 24, 2021. Qvents presents in this post the salient changes and...

Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024, Zydus' Jarod facility (FEI 3013712903) was issued a Warning Letter by the USFDA in August 2024. The facility was inspected in April 2024 by FDA...

The European Commission (EC) revoked the conditional marketing authorization (CMA) of Advanz Pharma’s Ocaliva (obeticholic acid) in Europe for the second-line treatment of patients with primary biliary cholangitis (PBC) in September 2024. However, Advanz Pharma has secured a temporary suspension...

CDSCO has published a drug alert regarding voluntary recall of Tisseel Lyo Fibrin Sealant VHS/D Powder and solvent for sealant by Baxter. The imported product is manufactured by Takeda in Vienna, Austria. The recall is is due to extended dissolution...

CDSCO has published the NSQ (Not of Standard Quality) alert for July 2024. The list published by CDSCO on 22 Aug 2024, lists fifty seven drug products and include common drugs like Paracetamol, Ofloxacin, Azithromycin, Aspirin, Pantoprazole, Diclofenac. More than...

Dr.Reddy’s laboratories Inc (DRL) has initiated recall of 50 batches of Ibuprofen tablets in US market. DRL is recalling Ibuprofen tablets of three different strengths – 800mg, 600mg and 400mg. The recall is initiated based on the results observed in...

FDA has given approval for Janssen’s New Molecular Entity Lazertinib (Lazcluze). Approval is accorded for Lazertinib in combination with amivantamab-vmjw (Rybrevant) for treatment of non-small cell lung cancer (NSCLC). Lazertinib is a kinase inhibitor of epidermal growth factor receptor. Rybrevant plus...

Latest circular issued by CDSCO on Good Distribution Practices (GDP) indicate that the guidance on GDP could be incorporated as a schedule in Drugs and Cosmetics Act, 1945. CDSCOs Drug Consultative Committee (DCC) apprehend that due to non-mandatory nature of...

Gilead announced FDAs approval of Livdelzi (Seladelpar) for treatment of PBC, a rare, chronic, autoimmune disease of the bile ducts. PBC can cause liver damage and possible liver failure if untreated. The disease currently has no cure. (FDA) granted accelerated...

The USFDA has announced the fiscal year (FY) 2025 rates for GDUFA III fees. The FY 25 fee show a steep hike of ANDA fee to ₹ 3,21,920 from $ 252,453 for FY 24, an increase of 27.5%. The new...

South Korean Drug Regulator MFDS imposed administrative penalties on GlaxoSmithKline (GSK), reports Korea Bio Medical Review. The penalties are for violation of regulations Pharmaceutical Affairs Act and Rules on the Safety of Pharmaceuticals and Other Drugs. According to the MFDS...

Zydus Pharmaceuticals (USA) Inc initiated recall of multiple lots of Verapamil Hydrochloride injection due to potential cross contamination with other products. Verapamil Hydrochloride is a calcium channel blocker medication used for the treatment of high blood pressure, angina. The drug...

CDSCO has published list of drugs which were found to be not of standard quality for the month of May 2024, during tests at CDSCO (Central) laboratories and State laboratories of the Drug Control Authority. The medicines which were found...

Cipla facility at Verna, Goa was audited by USFDA during June 2024 ending with issuance of USFDA form 483 with six observations. The site was inspected from 10 June to 21 June 2024 by three investigators Tamil Arasu, Eileen A.Liu...

Glenmark Pharmaceuticals is recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K due to failed dissolution. Following this, there was one more recall  of 21 batches of Potassium Chloride Capsules by American Health Packaging on...

FDA has issued final guidance on Circumstances that constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection in June 2024. This is the final version of the draft guidance that was issued in December 2022 on same title....

USFDA 483 issued to Dr.Reddys (DRL) API unit in Pydibhimavaram, India cites failure to validate all analytical methods, failure to maintain manufacturing processes in validated state, Investigations and root cause into OOS and failures were not scientifically sound. The 483...

EDQM has published the draft guideline on Content of the dossier for sterile substances for public consultation. For a sterile drug substance (API), sterilisation process should be described in CEP application along with data for validation of sterilisation method in...

The guidance provides information on how FDA decides goal dates for a drug application (ANDA, BLA, NDA) based on information provided in the Form 356h regarding Facility readiness. This is a program enhancement as described in the GDUFA Reauthorization Performance...

Eugia US LLC is recalling two more injectable products in US for failed impurities, degradation specifications. Four lots of Dexamethasone Sodium Phosphate injection is being recalled for out of specification (OOS) results of sulfonic acid adduct of dexamethasone phosphate impurity...

The scientific community mourns the loss of Dr.Akiro Endo, whose death was announced by the Tokyo University of Agriculture and Technology where Dr.Endo was a professor emeritus. Dr.Endo’s groundbreaking research has been compared to the discovery of penicillin and led...

USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site was inspected by investigators Arsen Karapetyan and Qiao Y Bobo and the Firm was issued USFDA 483 with 8 observations. Following the inspection, the site...

Glenmark recalled several lots of Rizatriptan Benzoate Tablets and Rizatriptan Benzoate Orally Disintegrating Tablets in US due presence of Nitrosamine impurities. The recall is triggered due to the Nitrosamine Drug Substance Related Impurity (NDSRI) N-Nitroso Desmethyl Rizatriptan results that are...

Elanco Animal Health announced that the USFDA has completed its comprehensive, multi-year review of Bovaer (3-NOP), a methane-reducing feed ingredient, and determined the product meets safety and efficacy requirements for use in lactating dairy cattle. Bovaer with active ingredient 3-Nitroxy...

Dr.Reddy’s (DRL) is recalling 1176 bottles of Sirolimus 1mg tablets (NDC 55111-653-01) in US for failed impurities in degradation specification. The recall was initiated on 1 May 2024. Sirolimus (also known as Rapamycin) is an immunosuppressant indicated for the prophylaxis...

Everest Organics Ltd (Telangana, India) was issued a GMP Non-Compliance Report with recommendation to suspend the CEP certificate for Omeprazole, by Norwegian Authority. The NCA report followed an inspection in February 2024 at its Sangareddy, Telengana site in which major...

CDSCO has issued spurious drug alert for five medicinal products. The spurious drug alert includes popular brands like Emcure’s Instgra (Dolutegravir tablets), Glenmark’s Telma -AM (Telmisartan & Amlodipine tablets) and Sun Pharma’s Rifagut 400 (Rifaximin tablets). Other drugs in the...

Aurobindo arm, Eugia Pharma Specialities facility at Bhiwadi, Rajasthan was issued USFDA 483 with seven observations following inspection in April -May 2024. The facility (FEI 3009883410) was inspected by USFDA investigators Justin A Boyd, Anastasia M Shields and Vaishali J...

USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations. The facility (FEI 3013712903) was inspected by USFDA investigators Justin A Boyd and Anastasia M Shields in April 2024. Major deficiencies observed were pertaining to...

The Drug Controller General of India (DCGI) has notified that effective from May 15, 2024, the issuance of Export No Objection Certificates (NOCs) for new, unapproved, and banned drugs will transition from State Licensing Authorities (SLAs) to Central Drugs Standard Control Organization (CDSCO)...

WHO has issued an alert on falsified Propylene glycol bearing name of Dow detected in Pakistan. Authentic Dow USP/EP propylene glycol is a Pharmaceutical raw material (excipient) adhering to the standards of the United States and European Pharmacopoeias (USP/EP) for...

The USFDA 483 issued to Sun Pharma, Dadra unit in India (FEI 3004561553) published by USFDA demonstrates the depths audits go to identify non compliances and highlights the evolving expectations of auditors. The site was inspected by USFDA investigator Pratik...

J&Js paediatric cough syrup Benylin is being recalled in several African countries following detection of high level of diethylene glycol contamination. The recall was triggered in Nigeria (April 10, 2024) after laboratory tests on a batch of  Benylin Paediatric showed...

The revised EDQM guideline “Content of the dossier for chemical purity and microbiological quality of substances for pharmaceutical use” will be effective from 1st May 2024. The  key updates are with regards to   information to be included in the Module...

As expected FDA has taken regulatory action and issued a Warning letter to Natco, following critical observations during inspection at Natco’s Kothur facility in India. The site was inspected in October 2023, by investigators Pratik S. Upadhyay and Saleem A....

USFDA Warning letter to Australian API manufacturer cites basic laboratory compliance issues - Inadequate OOS investigations, failure to follow USP monograph methods, laboratory records do not capture all relevant test details to establish traceability and validity of data and failure...

USFDA inspected Jubilant Generics Limited facility in Roorkee, India, from January 25th to February 2nd, 2024. The USFDA 483 issued at the close of inspection by investigators Jaffrey P. Raimondi and Tamil Arasu cites deficiencies on cleaning validations, inadequate investigations,...

Natco Pharma is recalling one more lot of Lanzoprazole 15 mg delayed release capsules for cGMP deviations in March 2024. The drug is distributed by Rising Pharma Holdings. Lanzoprazole is indicated for treatment of frequent heartburn. The Lanzoprazole capsules are...

The USFDA released draft guidance on New Dietary Ingredient Notification (NDIN) Master Files for dietary supplements in April 2024. Let's break down what this means for the industry. What are NDIs and NDINs? A New Dietary Ingredient (NDI) is any...

Glenmark has initiated a recall of one lot of Diltiazem Hydrochloride 120mg, Extended Release(ER) Capsules in US in Mar 2024. The class II recall is due to Failed Dissolution Specifications during long term stability studies at the at the 12th...

FDA has announced the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2024. These facility fees are effective on October 1, 2023, and will remain in effect...

FDA approved Akebia’s Vafseo (Vadadustat) for treatment of anaemia due to Chronic Kidney Disease (CKD) in patients receiving dialysis for at least three months. Vafseo is a once daily oral tablet and recommended starting dose 300 mg. Vafseo is available...

FDA has approved Merck’s Biologic drug Winrevair (Sotatercept-CSRK) for Pulmonary Arterial Hypertension (PAH). The product is available in 45mg and 60mg lyophilized cake or powder single dose vials for subcutaneous injection. The recommended starting dose is 0.3mg/kg and target dose...

Eugia US LLC is recalling one lot of Methocarbamol Injection in US for white particles observed to be floating in the vial. The recall follows a customer complaint. Particulates in injection has potential to cause stroke and even death if...

FDA has issued a new guidance for handling reserve samples from bioavailability (BA) and bioequivalence (BE) studies for study sponsors and/or drug manufacturers, contract research organizations (CROs), site management organizations (SMOs), and investigators. The guidance is for immediate implementation. The...

USFDA has approved Italfarmaco’s Duvyzat (givinostat) oral medication for treatment of Duchenne Muscular Dystrophy (DMD). Duvyzat is a non steroidal drug for treatment of DMD, a rare neurological disorder, characterised by progressive muscle weakness due to lack of muscle protein,...

USFDA has approved Idorsia's new drug Tryvio, a New Molecular Entity (NME) drug Aprocitentan for treatment of high blood pressure in patients who are not responding well to other medications. However, the approval comes with a black box warning, the...

EMA(Europeans Medicines Agency) has updated the Appendix 1 Acceptable intakes established for N-nitrosamines with 15 more substances in February 2024. The new list cover drug molecules Cyanocobalamine, Apixaban, Clozapine, Tamoxifen, Flecainide, Masitinib, Telmisartan, Meropenem, Methylphenidate, Silodosin and Terazosin. The list...

USFDA has updated Safety Communication on Chinese made plastic syringes. FDA had issued a Safety Communication on plastic syringes made in China earlier in November 2023. FDA’s concerns on Chinese made plastic syringes include performance & safety of the syringes,...

USFDA had inspected Aurobindo’s Eugia SEZ Pvt Ltd facility at Polepally, Telengana in India in Feb 2024. This was the third Eugia facility (FEI 3011905047) to be inspected by FDA in a span of 3 months after the Eugia US...

USFDA has issued a new guidance for primary batches to be included in the CMC section in Animal Drug Applications. The guidance is applicable for New Animal Drug Applications (NADAs), Abbreviated New Animal Drug Applications (ANADAs) and associated applications like...

FDA has approved Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) for treatment of fatty liver disease (Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with liver Fibrosis). The treatment is approved for adults with a once-daily, oral dosage of 80  - 100 mg based on actual body...

Dublin based Par Pharmaceutical, part of Endo International plc is recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) in US. The recall is due to potential presence of silicone particulates in the product solution. Particulates in injectable products can cause...

Eugia US LLC is recalling three lots of Methylprednisolone acetate Injectable Suspension (80mg/mL, 5mL Multiple-Dose Vial) in US. The Class II recall is initiated due to failed Dissolution Specifications. Methylprednisolone acetate injectable suspension is an anti-inflammatory glucocorticoid for intramuscular, intra-articular,...

Aurobindo’s Eugia SEZ Pvt. Ltd at Polepally Village, Mehaboob Nagar, Telengana was inspected by USFDA during 19-29th February 2024. Post inspection the facility was issued USFDA 483 with seven observations. Aurobindo in a press statement to stock exchanges declared that...

FDA issued a Warning letter to Amman Pharmaceuticals following inspection at the facility (FEI 3013501887) at Amman, Jordan in August 2023. The Warning letter highlights critical lapses including non aseptic operations and inadequate controls to prevent microbial contamination of sterile...

Indian Pharma company Orchid Pharma’s New Molecular Entity (NME) Enmetazobactam gets USFDA approval for treatment of complicated urinary tract infections (cUTI). The new drug EXBLIFEP is a combination drug of Enmetazobactam with Cefixime, a cephalosporin antibacterial. Exblifep is an injection...

USFDA Inspectors Anders W. Evenson and Arsen Karapetyan had inspected the Sichuan Deebio facility (FEI 3011139911) in September 2023. Serious deficiencies were observed during the audit with non-contemporaneous recording of laboratory data in Microbiology QC laboratory, missing test data (electronic...

Aurobindo arm Eugia Pharma site at Sangareddy, Telengana was inspected by USFDA in Jan -Feb 2024. Inspection was conducted by USFDA investigators Justin A Boyd, Eileen A Liu, Anastasia M Shields resulting in USFDA 483 with 9 observations. The 483...

The USFDA 483 issued to Sichuan Deebio Pharmaceutical Co. Ltd cite critical data integrity observations of Microbiology plates discarded in waste bin without recording results and QC team leader not telling truth about the results; missing test data and repeat...

In a Class 3 recall Teva initiated recall of one lot each of Nortrel and Nortrel 7/7/7. Nortrel and Nortrel 7/7/7 are oral contraceptive tablets with 21 therapeutically active coloured tablets containing the actives norethindrone and ethinyl estradiol and 7 white...

Prospective applicants of Complex Generics (CG) can request for a joint meeting with FDA OGD (Office of Generics Drugs) and EMA (European Medicines Agency) for scientific advice on development of the generics. Engaging with regulatory agencies at an early stage...

European Pharmacopoeia Commission (EPC) approved the new strategy for N-nitrosamine impurities in individual monographs in November 2023. As per the new strategy a specification for N-nitrosamine impurity will be included in a monograph only when it is a process-related impurity,...

Natco Pharma initiated a recall of one lot of Lanzoprazole 15mg capsules in US. Reason for recall is inadequate induction sealing of bottles and observation of capsules sticking together, active spheres sticking to capsules, capsules with holes and exposed drug,...

Each Drug Establishments (Registrants*) registered with FDA must provide information on amount of each listed drug manufactured to Agency under Section 510(j)(3) of the FD&C Act. This support agency’s efforts to reduce drug shortage risks. The requirement applies to each...

USFDA audit of Eugia US Manufacturing in New Jersey, US (FEI 3015534630) resulted in issuance of USFDA 483 with 10 observations. The inspection was performed from 11-22 December 2023 by investigators James R Birkenstamm, Daniel L Zheng, Ruben C Quintana,...

The USFDA announced next phase of the Quality Management Maturity (QMM) Program for drug manufacturers. FDA is seeking the participation of nine firms in the QMM program. FDA has developed a protocol with a series of questions in five practice...

Sun Pharma initiated recall of several drugs manufactured at Dadra site (India) for cGMP deviation - microbial contamination in stagnant water in the duct of manufacturing equipment. The drugs recalled include OSD Drugs Cinacalcet tablets, Febuxostat tablets, Lurasidone tablets, Mesalamine Delayed-Release...

The draft guidance Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products (CVM GFI #286 (VICH GL60)) is issued by Centre for Veterinary Medicine (CVM). This guideline is developed based on ICH Q7: Good Manufacturing Practices for...

Dr Reddys (DRL) initiated recall of one batch of Tizanidine 4mg tablets in US in January 2024. The recall is due to presence of foreign tablet - Tizanidine 2mg tablets in the bottle of Tizanidine 4mg tablets. Tizanidine is a...

Lupin recalled 3 batches of Desloratadine tablets in Dec 2023 for N-Nitroso Desloratadine impurity exceeding acceptable intake (AI) limit. Desloratadine is an antihistamine for treatment of allergies, such as sneezing, itching, and runny nose. USFDA Enforcement Report – Lupin Desloratadine...

USFDA has launched a new search page for Quality documents. The page provides useful links to Pharma Quality related documents  - Guidance’s, Compliance Programs, MAPP (Manual of Policies and Procedures).  USFDA website and archives have a large repository of useful...

This guidance provides procedures for ANDA applicants who wish to pursue a request for reconsideration on a FDA decision or action related to ANDAs. Regulatory actions eligible for a request for reconsideration include Refuse-to-receive decision Tentative approval letter Complete response...

Due to an incident of “foreign capsule” in the bottle, Dr.Reddy’s initiated a voluntary recall of a batch of  Tacrolimus 1mg capsules in US. A 0.5mg Tacrolimus capsule was observed in a bottle of 1mg Tacrolimus capsules, which led to...

FDA inspected the Drug Testing Establishment of DRL (Dr.Reddy’s Laboratories) at Bachupally, Telengana India (FEI:3009483004) in Dec 2023; USFDA Investigator Saleem A Akhtar. The Form 483 issued cites discrepancies in sameness study conducted in 2016 between DRL drug product and...

Torrent’s Chhatral, Gujarat facility (FEI: 3012740315) was inspected by USFDA (Investigator Yvins Dezan) in Dec 23. The inspection resulted in USFDA 483 with five observations. Observations include failure to review discrepancies thoroughly, deficiencies in procedures, cleaning and maintenance of equipment....

USFDA inspected Laurus Synthesis, Visakh facility in India (FEI: 3011524794) in Dec 2023 by investigators Joseph A. Piechocki and Rafeeq A. Habeeb. The USFDA 483 reports five observations including lapses in investigations of equipment damage and potential particulate contamination; deficiencies...

FDA has published a revised guidance on quality considerations for topical ophthalmic drug products – Gels, Ointments, Creams, Solutions, Suspensions and emulsions. The revised guideline is an update to the initial guidance published in October 2023. This revision adds Microbiological...

Hospira Inc., a Pfizer company announced recall of several injectable products in US for potential glass particulates in vials. Three of the products recalled are 4.2% Sodium Bicarbonate Injection (NDC 0409-5534-24); 8.4% Sodium Bicarbonate Injection (NDC 0409-6637-24); Atropine Sulfate Injection...

FDA has updated MAPP for assessment of requests for reclassification of facility-based major complete response (CR) letter amendments. On December 21, FDA published a revised CDER manual of policies and procedures (MAPP) to assess requests for reclassification of facility-based major...

The letter to FDA was written by the Republican members of the E&C committee of the US Congress Representatives and signed by Chair Cathy McMorris Rodgers and other Republican subcommittee chairs and members. The letter raised questions about the FDA’s...

China’s revision of counter espionage laws in April 2023, with enumeration of espionage activities extended to include Stealing, prying into, purchasing, or illegally providing … other documents, data, materials, or items related to national security and interests has concerns for...

The GMP/GDP Inspectors Working Group coordinated by EMA has decided to continue the extension of the validity of the GMP and GDP certificates until 2024 or the conclusion of the next on-site inspection, whichever comes first. EMA, the European Commission...

The European Commission has published the first Union list of critical medicines, together with the European Medicines Agency (EMA) and the Member States' Heads of Medicines Agencies (HMA). This first Union critical medicines list contains more than 200 active substances...

MHRA has decided to continue the extension of the validity GMP & GDP Certificates until 2024 or until the conclusion of the next inspection, whichever comes first. GMP / GDP inspections were postponed during Covid 19 emergency and the validity...